(251 days)
N1™ TiUltra™ TCC Implant system is indicated for use in the maxilla or mandible for anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function. N1™ TiUltra™ TCC Implant system is indicated for single or multiple unit restorations in splinted or non-splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, given that sufficient primary stability and appropriate occlusal loading for the selected technique has been achieved.
N1 TiUltra TCC Implant system is composed of implant site preparation tools, abutments, and abutment screws.
The provided text describes the regulatory clearance of a dental implant system (N1™ TiUltra™ TCC Implant system) and outlines the testing conducted to demonstrate its substantial equivalence to predicate devices. However, it does not contain information typically found in a clinical study report that would detail acceptance criteria and a study proving the device meets those criteria in the context of diagnostic or screening performance (e.g., sensitivity, specificity, accuracy).
Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technological characteristics, intended use, indications for use, and comprehensive non-clinical and clinical testing. The concept of "acceptance criteria" here refers to demonstrating that the new device is as safe and effective as the predicate, rather than meeting specific performance metrics for a diagnostic task.
Therefore, I will interpret "acceptance criteria" as the criteria for establishing substantial equivalence and "reported device performance" as the outcomes of the non-clinical and clinical studies conducted to support that equivalence.
Here's a breakdown of the information based on the provided text, addressing your specific questions, with explanations for what is not present:
1. Table of acceptance criteria and the reported device performance
Since this is a submission for substantial equivalence, the "acceptance criteria" are demonstrating similarity to predicate devices and acceptable performance in various non-clinical and clinical tests.
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (N1™ TiUltra™ TCC Implant system) |
|---|---|
| Substantial Equivalence in Intended Use and Indications for Use. | N1™ TiUltra™ TCC Implant system shares the same or similar intended use and indications for use as predicate devices, with differences adequately addressed. |
| Sterilization Validation (SAL 10⁻⁶) | Successfully demonstrated sterility assurance level of 10⁻⁶ via gamma sterilization, confirming safety for use. |
| Endotoxin Levels (meeting USP <161>, <85>, ANSI/AAMI ST72) | Testing confirmed endotoxin levels are within acceptable limits, demonstrating pyrogen-free status. |
| End-User Cleaning & Sterilization Validation (for reusable components) | Validation performed per ISO 17665-1, AAMI TIR12, AAMI/ANSI ST79, ANSI/AAMI ST77, ISO 17664, ensuring safe reprocessing for reusable components. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Packaging Performance (maintaining sterility and device integrity) | Met standards (ISO 11607-1, ASTM D4169, D4332, F1886/F1886M, F2096, F1980), demonstrating packaging efficacy in maintaining sterility and integrity. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Biocompatibility (ISO 10993-1, -5, -12, -18) | All materials passed biocompatibility tests (cytotoxicity, chemical characterization), confirming safety for patient contact. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Mechanical Resistance (ISO 14801, FDA Guidance) | Demonstrated sufficient fatigue resistance and mechanical stability in dynamic loading tests, comparable to predicate devices. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Insertion Parameters (Heat Generation, Torque) | Comparative testing demonstrated equivalence in heat generation and insertion torque to the Primary Predicate, indicating similar surgical experience and bone response. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Osseointegration (Animal Study) | Animal study showed representative osseointegration behavior comparable to the predicate (TiUltra Implants and Xeal Abutments) at 13 ± 2 weeks, supporting the new drilling technique. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Mesostructure Design & Manufacturing (Software & E2E Validation) | Software verification for abutment design library ensured adherence to design limitations; validation confirmed locked specifications, and end-to-end (E2E) validation demonstrated proper manufacturing workflow. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| MR Conditional Labeling (Referencing K212125) | Met acceptable outcomes in MR conditional testing for safe use in specific MR environments, leveraging prior clearance. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Long-term Clinical Performance (MBLC, Survival, Safety, Tissue Health) | Primary Endpoint (MBLC): Non-inferiority to historical data for the predicate device (NobelActive implant system) was met with statistical significance (p<0.001) for Marginal Bone Level Change, showing increased bone of 0.15 ± 0.84 mm (n=124 implants) from loading to 12-months post-loading. Secondary Endpoints: Implant survival, implant success, tissue health, and safety events (adverse events) resulted in clinically favorable outcomes. |
| Post-Market Surveillance (PMS) | Complaint rates for the subject device were found to be lower than the predicate device during its first year of marketing. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
2. Sample size used for the test set and the data provenance
- Non-Clinical Testing: Sample sizes are not explicitly stated for most non-clinical tests (e.g., sterilization, endotoxin, biocompatibility, packaging, mechanical). The animal study involved a "mini-pig model" but the number of animals or implants within that study is not specified, only that it served a comparative purpose. For heat generation and insertion torque, comparative testing was done between the subject device and the Primary Predicate, but specific numbers are not given.
- Clinical Testing (T-193 EVOLUTION Study):
- Sample Size: 95 consecutive subjects, treated with 165 implants. 145 implants had 12-month follow-up visit data after loading. Marginal bone level change (MBLC) analysis was based on n=124 implants for paired image analysis.
- Data Provenance: Retrospective, multi-center, company-sponsored real-world study, conducted in Europe.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish ground truth for the clinical study. The "ground truth" in this context would likely refer to the clinical assessments and measurements (e.g., marginal bone level change, implant survival, soft tissue parameters) recorded by the medical professionals involved in the multi-center European study. It does not mention an independent expert panel for ground truth adjudication outside of the routine clinical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method (like 2+1 or 3+1) for the clinical study data. The data appears to be collected and reported directly from the clinical sites as part of a real-world study.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study (evaluating human reader performance with and without AI assistance) is typically performed for diagnostic imaging AI devices. The N1™ TiUltra™ TCC Implant system is a dental implant system (hardware), not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. As mentioned, this is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical testing (T-193 EVOLUTION Study), the "ground truth" was established through:
- Outcomes Data / Clinical Data: Marginal bone level change (MBLC), implant survival, implant success rates, soft tissue healing parameters (bleeding index, plaque index), and adverse events, collected directly from clinical practice.
- Radiographic Imaging Data: Used for MBLC assessment.
- Comparative Reference: Historical data from published literature for the predicate NobelActive implant system (MacLean et al., 2016, and Aldahlawi, et al., 2018) was used for non-inferiority comparison of MBLC.
- Animal Study: Micro-CT, histology, and histomorphometry were used to assess osseointegration.
8. The sample size for the training set
This information is not applicable as the document describes a physical medical device product and its substantial equivalence testing, not an AI/ML algorithm that would typically require a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above (not an AI/ML algorithm).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a solid blue square and the full name written in a smaller font next to it.
Nobel Biocare Services AG Bernice Jim Head of RA Product Development and Marketed Products Balz Zimmermann-Str. 7 Kloten, Zurich 8302 SWITZERLAND
Re: K211109
Trade/Device Name: N1TM TiUltra™ TCC Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA, PNP, QRQ Dated: November 18, 2021 Received: November 19, 2021
Dear Bernice Jim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K21109
Device Name
N1™ TiUltra™ TCC Implant system
Indications for Use (Describe)
N1™ TiUltra™ TCC Implant system
NI™ TiUltra™ TCC Implant system is indicated for use in the maxilla or mandible for anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function. NI™ TiUltra™ TCC Implant system is indicated for single or multiple unit restorations in splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, given that sufficient primary stability and appropriate occlusal loading for the selected technique has been achieved.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Form 3881 (Cont.)
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2023 |
|---|---|
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) | |
| K211109 | |
| Device Name | |
| N1TM TiUltraTM TCC Implant system | |
| Indications for Use (Describe) (Cont.) | |
| Nobel Biocare N1TM TiUltraTM TCC implants | |
| N1TM TiUltraTM TCC Implant system is indicated for use in the maxilla or mandible for anchoring orsupporting prosthetic teeth, in order to restore patient esthetics and chewing function. N1TMTiUltraTM TCC Implant system is indicated for single or multiple unit restorations in splinted or non-splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate,early or delayed loading protocols, given that sufficient primary stability and appropriate occlusalloading for the selected technique has been achieved. | |
| OsseoShaper 1 Nobel Biocare N1TM and OsseoShaper 2 Nobel Biocare N1TM | |
| The N1TM system Implant Site Preparation Tools are indicated to be used in the maxilla or mandibleto prepare an osteotomy prior to placement of a Nobel Biocare N1TM TiUltraTM TCC implant. | |
| Cover Screw Nobel Biocare N1TM TCC | |
| To be used when applicable together with the implant during healing in order to protect the implantplatform and internal threads from overgrowth of bone. | |
| Multi-unit Abutment Xeal Nobel Biocare N1TM TCC | |
| Multi-unit Abutment TCC is a premanufactured prosthetic component directly connected to theendosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. | |
| Universal Abutment Nobel Biocare N1TM TCC | |
| Universal abutments are indicated to support the placement of single unit, screw- retained prostheticrestorations in the maxilla or mandible. | |
| The Universal Abutment consists of two major parts. Specifically, the titanium base andmesostructure components make up a two-piece abutment. | |
| The system integrates multiple components of the digital dentistry workflow scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associatedtooling and accessories. |
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Form 3881 (Cont.)
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2023 |
| Indications for Use | See PRA Statement below. |
The Universal Abutment Nobel Biocare N1™ Base consist of three major parts. Specifically, the N1 Base Xeal, the Universal Abutment N1 Base, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
Nobel Biocare N1™ Base Xeal™
The Nobel Biocare N1™ Base Xeal™ is indicated for use in the maxilla or mandible for supporting tooth replacements to restore chewing function. It is indicated for single unit restorations and multiple unit restorations up to 6 units with less than 20° divergence to allow path of insertion.
Universal Abutment Nobel Biocare N1™ Base Tri
The Universal Abutment Nobel Biocare N1™ Base Tri is indicated to support the placement of single unit, screw-retained prosthetic restorations in the maxilla or mandible.
Universal Abutment Nobel Biocare N1™ Base Tri Bridge
The Universal Abutment Nobel Biocare N1™ Base Tri Bridge is indicated to support the placement of multiple unit of up to 6 units. screwretained prosthetic restorations in the maxilla or mandible for implants with less than 20° overall divergences to allow path of insertion.
Healing Abutment Nobel Biocare N1™ TCC
Healing abutments are indicated for use with endosseous dental implants in the maxilla or mandible for supporting single tooth to full arch denture procedures. Healing abutments Nobel Biocare N17M TCC are indicated for use for up to 180 days.
Temporary Abutment Nobel Biocare N1™ TCC
Are indicated for use with single unit screw-retained temporary dental prostheses placed on endosseous dental implants in the maxilla and mandible, for up to 180 days.
Healing Abutment Nobel Biocare N1TM Base Tri
The Healing Abutment Nobel Biocare N1™ Base is indicated for use with the Nobel Biocare N1™ Base Xeal™ in the maxilla or mandible for supporting single unit and multiple unit procedures, for up to 180 days.
Temporary Abutment Nobel Biocare N1™ Base Tri
The Temporary Abutment Nobel Biocare N1™ Base is indicated to support the placement of single unit, screw-retained temporary prosthetic restorations in the maxilla or mandible, for up to 180 days.
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Form 3881 (Cont.)
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2023 |
| Indications for Use | See PRA Statement below. |
Temporary Abutment Nobel Biocare N1TM Base (Bridge)
The Temporary Abutment Nobel Biocare N1™ Base Bridge is indicated to support the placement of multiple unit, screw-retained temporary prosthetic restorations in the maxilla or mandible, for up to 180 days for implants with less than 20° overall divergences to allow path of insertion.
IOS Healing Abutment Nobel Biocare N1™ Base Tri
The IOS Healing Abutment Nobel Biocare N1™ Base is indicated for use with the Nobel Biocare N1™ Base Xeal™ in the maxilla or mandible for supporting single unit and multiple unit procedures, for up to 180 days. In combination with intraoral scanner the IOS Healing Abutment can be used to confirm the location, position, and orientation of the Nobel Biocare N1™ Base Xeal™, to support creation of the digital model to facilitate the design and fabrication of a dental prosthesis using CAD/CAM.
Clinical Screw Nobel Biocare N1™ Base and Prosthetic Screw Nobel Biocare N1™ Base
The Clinical and Prosthetic Screw are to be directly connected to the dental implant, abutment or framework, intended for use as an aid in prosthetic rehabilitation.
Clin Screw Multi-unit Abut Nobel Biocare N1™ TCC and Clinical Screw Nobel Biocare N1™ TCC
Clinical Screws are to be directly connected to the dental implant, abutment or framework, intended for use as an aid in prosthetic rehabilitation.
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Image /page/6/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red square with a stylized white "N" inside of it. To the right of the square is the text "Nobel Biocare" in black font, with the "TM" symbol in superscript.
510(k) Notification K211109
Submitter:
Nobel Biocare AB P.O. Box 5190, 402 26 Västra Hamngatan 1 Goteborg, SE-411 17 Sweden
Submitted by:
Nobel Biocare Services AG Balz Zimmermann-Str. 7 8302 Kloten Switzerland
| Contact Person: | Bernice Jim, Ph.D. |
|---|---|
| E-Mail: | regulatory.affairs@nobelbiocare.com |
| Date Prepared: | 21 December 2021 |
Device:
| Trade Name: | N1™ TiUltra™ TCC Implant system |
|---|---|
| Manufacturer: | Nobel Biocare AB |
| Generic/Common Name: | Dental Implants |
| Regulation Name: | Endosseous Dental Implant |
| Regulation Number: | 21 CFR§872.3640 |
| Regulatory Class: | II |
| Product Code: | DZE |
| Secondary Product Codes: | NHA, PNP, QRQ |
Predicate Devices:
The predicate and reference devices used in this 510(k) submission are described in Table 5.1.
| Table 5.1: Predicate and Reference Devices for the N1™ TiUltra™ TCC Implant system | ||||
|---|---|---|---|---|
| (N1™ svstem) |
| Device | 510(k) | Manufacturer | |
|---|---|---|---|
| Primary Predicate | NobelActive | K142260 | Nobel Biocare AB |
| Reference #1 | TiUltra Implants and Xeal Abutments | K202344 | Nobel Biocare AB |
| Reference #2 | NobelActive Wide Platform (WP) | K133731 | Nobel Biocare AB |
| Reference #3 | On1 Concept | K161655 | Nobel Biocare AB |
| Reference #4 | Branemark Novum | K000018 | Nobel Biocare UAS Inc. |
| Reference #5 | Universal Base Conical Connection (CC) | K200040 | Nobel Biocare AG |
| Reference #6 | On1 Universal Abutment | K181869 | Nobel Biocare AB |
| Reference #7 | Multi-unit Abutment Plus | K161416 | Nobel Biocare AB |
| Reference #8 | Nobel Biocare Dental Implant SystemsPortfolio - MR Conditional | K212125 | Nobel Biocare AG |
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In compliance with the FDA Guidance Document entitled, "Bundling Multiple Devices or Multiple Indications in a Single Submission," issued June 22, 2007, Nobel Biocare has prepared a single submission for the N1™ TiUltra™ TCC Implant system because the submission represents a system of devices used together for a dental procedure which has similar supportive data, and one FDA review division will be involved.
Device Description
N1 TiUltra TCC Implant system is composed of implant site preparation tools, abutments, and abutment screws. Table 5.2 provides the Device Lines that when used together form the N1 TiUltra TCC Implant system.
| Subject Device | Item No. | Device Lines | Description |
|---|---|---|---|
| N1™ TiUltra™TCC Implantsystem | 1 | Nobel Biocare N1™ TiUltra™TCC implants | Endosseous dental implant |
| 2 | OsseoShaper | Instruments for bone preparation | |
| 3 | Multi-unit Abutment Xeal™Nobel Biocare N1™ TCC | Endosseous dental abutment | |
| 4 | Universal Abutments NobelBiocare N1™ | Endosseous dental abutment | |
| 5 | Temporary Abutments | Endosseous dental abutment | |
| 6 | Screws | Screws for endosseous dentalabutments |
Table 5.2: Devices Included in this 510(k) Submission
The device description for the seven Device Lines are as follows:
Nobel Biocare N1™ TiUltra™ TCC implants (Item 1):
N1 TiUltra TCC Implant system consists of a dental implant (i.e., Nobel Biocare N11" TiUltra™ TCC implants) featuring the Tri-oval Conical Connection (TCC), which is characterized by a tri-oval shaped coronal zone and a round, moderately tapered body. It is intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function to partially or fully edentulous patients.
The Nobel Biocare N1 TiUltra TCC implants Device Line also includes the Cover Screw Nobel Biocare N1™ TCC ("Cover Screw"), which is a Device Component that covers the implant platform and prevents tissue overgrowth during the healing phase of the placed implant. The threaded portion of the Cover Screw fits inside the internal thread of the implant, while the head of the Cover Screw covers the inner surface of the implant (i.e., the implant connection).
OsseoShaper (Item 2):
The OsseoShapers are rotating implant site preparation tools to be used at low speed (50rpm) without irrigation. The implant can be placed as soon as the OsseoShaper 1 Nobel Biocare N1™ ("OsseoShaper 1") has reached the desired depth and position in accordance with the preoperative planning at a torque value of <40 Ncm. The
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OsseoShaper 2 Nobel Biocare N1™ ("OsseoShaper 2") is intended to be used when the OsseoShaper 1 does not reach the desired depth and position in accordance with the preoperative planning and at a torque of <40 Ncm. The OsseoShapers work in conjunction with traditional implant placement accessories not subject to this submission (e.g., Guided Pilot Drill).
Multi-unit Abutment Xeal™ Nobel Biocare N1™ TCC (Item 3):
The Multi-unit Abutments Xeal™ Nobel Biocare N1™ TCC are transmucosal abutments used for multiple unit screw retained restorations. The Multi-unit Abutments Xeal Nobel Biocare N1 TCC are available in Narrow Platform (NP) and Regular Platform (RP), feature a tri-oval conical connection (TCC), and are compatible with the Nobel Biocare N1 TiUltra TCC implants.
Universal Abutments Nobel Biocare N1™ (Item 4):
The Universal Abutment Nobel Biocare N1™ Device Line consists of the following Device Components:
- Universal Abutment Nobel Biocare N1™ TCC .
- Universal Abutment Nobel Biocare N1™ Base Tri ●
- Universal Abutment Nobel Biocare N1™ Base Tri (Bridge) ●
- Nobel Biocare N1™ Base Xeal™ TCC Tri .
The Universal Abutment Nobel Biocare N1™ Device Line are pre-manufactured dental implant abutments which can be either connected directly to a Nobel Biocare N1 TiUltra TCC implant, featuring the tri-oval conical connection, or to a Nobel Biocare N1 Base Xeal TCC Tri to support the placement of a screw-retained dental prosthesis.
The digital workflow requires the use of the following equipment and materials:
| Equipment / Material | Minimum Requirements |
|---|---|
| Scanner | Kavo LS3, 3Shape Trios, or other scanners with accuracy equal or higher than 6.9 µm |
| Design Software | DTX Studio Lab(The Implant Libraries are automatically included in the software installer) or3Shape Dental Designer(The Implant Libraries are obtained via the 3Shape server in the software). |
| Restorative Material | Nacera Pearl Doceram Medical CeramicsMinimum wall thickness allowed: $\leq$ 0.5 mm |
| Milling Unit | Roland DWX-52D |
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| Primer | Monobond Plus by Ivoclar Vivadent |
|---|---|
| Adhesive | Multilink Hybrid by Ivoclar Vivadent |
| Glycerin Gel | Liquid Strip by Ivoclar Vivadent |
The bonding procedure requires the use of following materials:
Temporary Abutments (Item 5):
The Temporary Abutments Device Line consists of the following abutments:
- Healing Abutment Nobel Biocare N1™ TCC ●
- Healing Abutment Nobel Biocare N1™ Base Tri ●
- Temporary Abutment Nobel Biocare N1™ TCC ●
- Temporary Abutment Nobel Biocare N1™ Base Tri ●
- Temporary Abutment Nobel Biocare N1™ Base (Bridge) ●
- IOS Healing Abutment Nobel Biocare N1™ Base Tri ●
The Healing Abutment Nobel Biocare N1 TCC and Healing Abutment Nobel Biocare N1 Base Tri are pre-manufactured dental implant abutments which can be either connected directly to a Nobel Biocare N1 TiUltra TCC implant, for the Healing Abutment Nobel Biocare N1 TCC, or to a Nobel Biocare N1 Base Xeal TCC Tri, for the Healing Abutment Nobel Biocare N1 Base Tri, to support healing of the surrounding soft tissue. The TCC connection interface is featured on the Healing Abutment Nobel Biocare N1 TCC, whereas the Healing Abutments Nobel Biocare N1 Base Tri feature the N1 1 Prosthetic Connection.
The Temporary Abutment Nobel Biocare N1 TCC is a pre-manufactured dental implant abutment which can be either connected directly to a Nobel Biocare N1 TiUltra TCC implant, for the Temporary Abutment Nobel Biocare N1 TCC, or to a Nobel Biocare N1 Base Xeal TCC Tri to support the placement of a temporary dental prosthesis. The Temporary Abutment Nobel Biocare N1 Base Tri and Temporary Abutment Nobel Biocare N1 Base (Bridge) are pre-manufactured dental implant abutments which are placed on top of the Nobel Biocare N1 Base Xeal TCC Tri to support the placement of a temporary dental prosthesis. The TCC connection interface is featured on the Temporary Abutment Nobel Biocare N1 TCC whereas the Temporary Abutment Nobel Biocare N1 Base Tri and Temporary Abutment Nobel Biocare N1 Base Tri (Bridge) feature the N1™ Prosthetic Connection.
The IOS Healing Abutment Nobel Biocare N1 Base Tri is a pre-manufactured dental implant abutment which can be connected to a Nobel Biocare N1 Base Xeal TCC Tri to support healing of the surrounding soft tissue and to facilitate the transfer of an intraoral location of the Nobel Biocare N1 Base Xeal TCC Tri from the patient's jaw to the relative position on a master cast in the dental laboratory using an intra-oral scanning procedure. The connection interface for the IOS Healing Abutment Nobel Biocare N1 Base Tri is the N1™ Prosthetic Connection.
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Screws (Item 6):
The Nobel Biocare N1 TiUltra TCC Implant system contains the following abutment screws:
- Clin Screw Multi-unit Abut Nobel Biocare N1™ TCC ●
- Prosthetic Screw Nobel Biocare N1™ Base ●
- Clinical Screw Nobel Biocare N1™ Base .
- Clinical Screw Nobel Biocare N1™ TCC ●
Clinical and Prosthetic Screws of the N1 system are pre-manufactured dental implant screws designed to fix dental prostheses or dental implant system components such as implant abutments and implant healing abutments to an endosseous dental implant or to an endosseous dental abutment.
Indications for Use:
N1™ TiUltra™ TCC Implant system
N1™ TiUltra™ TCC Implant system is indicated for use in the maxilla or mandible for anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function. N1™ TiUltra™ TCC Implant system is indicated for single or multiple unit restorations in splinted or non-splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, given that sufficient primary stability and appropriate occlusal loading for the selected technique has been achieved.
Nobel Biocare N1™ TiUltra™ TCC implants
N1™ TiUltra™ TCC Implant system is indicated for use in the maxilla or mandible for anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function. N11 TiUltra™ TCC Implant system is indicated for single or multiple unit restorations in splinted or non-splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, given that sufficient primary stability and appropriate occlusal loading for the selected technique has been achieved.
OsseoShaper 1 Nobel Biocare N1™ and OsseoShaper 2 Nobel Biocare N1™
The N1" system Implant Site Preparation Tools are indicated to be used in the maxilla or mandible to prepare an osteotomy prior to placement of a Nobel Biocare N1™ TiUltra™ TCC implant.
Cover Screw Nobel Biocare N1™ TCC
To be used when applicable together with the implant during in order to protect the implant platform and internal threads from overgrowth of bone.
Multi-unit Abutment Xeal Nobel Biocare N1™ TCC
Multi-unit Abutment TCC is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
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Universal Abutment Nobel Biocare N1™ TCC
Universal abutments are indicated to support the placement of single unit, screw- retained prosthetic restorations in the maxilla or mandible.
The Universal Abutment consists of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment.
The system integrates multiple components of the digital dentistry workflow scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
The Universal Abutment Nobel Biocare N1™ Base consist of three major parts. Specifically, the N1 Base Xeal, the Universal Abutment N1 Base, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
Nobel Biocare N1™ Base Xeal™
The Nobel Biocare N1™ Base Xeal™ is indicated for use in the maxilla or mandible for supporting tooth replacements to restore chewing function. It is indicated for single unit restorations and multiple unit restorations up to 6 units with less than 20° divergence to allow path of insertion.
Universal Abutment Nobel Biocare N1™ Base Tri
The Universal Abutment Nobel Biocare N1™ Base Tri is indicated to support the placement of single unit, screw-retained prosthetic restorations in the maxilla or mandible.
Universal Abutment Nobel Biocare N1™ Base Tri Bridge
The Universal Abutment Nobel Biocare N1™ Base Tri Bridge is indicated to support the placement of multiple unit of up to 6 units, screwretained prosthetic restorations in the maxilla or mandible for implants with less than 20° overall divergences to allow path of insertion.
Healing Abutment Nobel Biocare N1™ TCC
Healing abutments are indicated for use with endosseous dental implants in the maxilla or mandible for supporting single tooth to full arch denture procedures. Healing abutments Nobel Biocare N1™ TCC are indicated for use for up to 180 days.
Temporary Abutment Nobel Biocare N1™ TCC
Are indicated for use with single unit screw-retained temporary dental prostheses placed on endosseous dental implants in the maxilla and mandible, for up to 180 days.
Healing Abutment Nobel Biocare N1™ Base Tri
The Healing Abutment Nobel Biocare N1™ Base is indicated for use with the Nobel Biocare N1™ Base Xeal™ in the maxilla or mandible for supporting single unit and multiple unit procedures, for up to 180 days.
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Temporary Abutment Nobel Biocare N1™ Base Tri
The Temporary Abutment Nobel Biocare N1™ Base is indicated to support the placement of single unit, screw-retained temporary prosthetic restorations in the maxilla or mandible, for up to 180 days.
Temporary Abutment Nobel Biocare N1™ Base (Bridge)
The Temporary Abutment Nobel Biocare N1™ Base Bridge is indicated to support the placement of multiple unit, screw-retained temporary prosthetic restorations in the maxilla or mandible, for up to 180 days for implants with less than 20° overall divergences to allow path of insertion.
IOS Healing Abutment Nobel Biocare N1™ Base Tri
The IOS Healing Abutment Nobel Biocare N1™ Base is indicated for use with the Nobel Biocare N1™ Base Xeal™ in the maxilla or mandible for supporting single unit and multiple unit procedures, for up to 180 days. In combination with intraoral scanner the IOS Healing Abutment can be used to confirm the location, position, and orientation of the Nobel Biocare N1™ Base Xeal™, to support creation of the digital model to facilitate the design and fabrication of a dental prosthesis using CAD/CAM.
Clinical Screw Nobel Biocare N1™ Base and Prosthetic Screw Nobel Biocare N1™ Base
The Clinical and Prosthetic Screw are to be directly connected to the dental implant, abutment or framework, intended for use as an aid in prosthetic rehabilitation.
Clin Screw Multi-unit Abut Nobel Biocare N1™ TCC and Clinical Screw Nobel Biocare N1™ TCC
Clinical Screws are to be directly connected to the dental implant, abutment or framework, intended for use as an aid in prosthetic rehabilitation.
Comparison of Technological Characteristics
Nobel Biocare N1 TiUltra TCC implants
The subject device, Nobel Biocare N1 TiUltra TCC implants have the same intended use and similar Indications for Use as NobelActive - K142260 (Primary Predicate) as the only difference is choice of similar wording. The Subject Device and Primary Predicate are endosseous dental implants to support prosthetic devices in order to restore patient esthetics and chewing function. Therefore, the devices are substantially equivalent in consideration of the intended use and Indications for Use.
Further, the devices are highly consistent with respect to technological characteristics. Both devices have the same material and have the same surface treatment. In addition, both devices have the same range of implant lengths, implant diameters, and platform compatibility.
There are technological differences (i.e., connection interface, macro design, surface topography, surface preservation, Instructions for Use, and packaging) between the Nobel Biocare N1 TiUltra TCC implants, and the Primary Predicate, however, these differences do not affect the shared intended use, between the devices, nor raise different questions of substantial equivalence as demonstrated by non-clinical and clinical testing.
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Cover Screw
The Cover Screw has the same intended use and similar Indications for Use as the cover screws for NobelActive – K142260 (Primary Predicate), as the only differences are the choice of similar wording. Both devices are intended to be connected to a dental implant in order to protect the implant during the healing phase. Therefore, the devices are substantially equivalent in the consideration of intended use and Indications for Use.
Further, the devices are highly consistent with respect to technological characteristics. Both devices have the same material, gingival height, packaging, sterilization characteristics, and a similar range in diameters.
There are technological differences (i.e., design, connection interface and surface treatment) between the Cover Screw and the Primary Predicate however, these differences do not affect the shared intended use, between the devices, nor raise different questions of substantial equivalence as demonstrated by non-clinical testing.
OsseoShapers
The OsseoShapers have the same intended use and similar Indications for Use as the Screw Tap from NobelActive – K142260 (Primary Predicate), as both devices are intended to be used to cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement. The only differences are the choice of similar wording. Therefore, the devices are substantially equivalent in the consideration of intended use and Indications for Use.
Further, the devices are highly consistent with respect to technological characteristics. Both devices have the same tip design, are compatible with ISO 1797 Type 1 handpiece connections, have insertion depth markings, and use no irrigation during transient surgical use.
There are technological differences (i.e., design, materials and surface treatment, drill speed, reusability, and packaging) between the OsseoShapers and the Primary Predicate, however, these differences do not affect the shared intended use, between the devices, nor raise different questions of substantial equivalence as demonstrated by non-clinical testing.
Multi-unit Abutment Xeal Nobel Biocare N1 TCC
The Multi-unit Abutment Xeal Nobel Biocare N1 TCC has the same intended use and Indications for Use as the Multi-unit Abutment Xeal™ from TiUltra Implants and Xeal Abutments - K202344 (Reference #1). Both abutment devices are premanufactured prosthetic components directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. Therefore, the devices are substantially equivalent in the consideration of intended use and Indications for Use.
Further, the devices are highly consistent with respect to technological characteristics. Both devices are composed of the same material, have the same range of device lengths, widths, and platforms, and feature the Xeal surface with the soluble salt (protective) layer.
There is only one technological difference (i.e., connection interface) between the Multi-unit Abutment Xeal Nobel Biocare N1 TCC and Reference #1, however, this difference does not affect the shared intended use, between the devices, nor raise different questions of substantial equivalence as demonstrated by non-clinical testing.
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Universal Abutments Nobel Biocare N1 (UA N1)
The UA N1 has the same intended use as the On1 Base Xeal™ and Multi-unit Abutment Xeal™ from TiUltra Implants and Xeal Abutments – K202344 (Reference #1), the only difference is the choice of similar wording. Both devices are abutment components which are intended to be used with endosseous dental implants and be used as an aid in prosthetic rehabilitation. In addition, both devices have similar Indications for Use as it describes the number of abutment major parts and the associated workflow. Specifically, both Indications for Use indicate for one or more titanium base elements and mesostructure components making up a two- or multi-piece abutment. Further, both abutment systems integrate multiple components of the digital dentistry workflow scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The Indications for Use of Universal Base Conical Connection (CC) – K200040 (Reference #5) is also similar as it indicates for a two major part abutment with the same digital dentistry workflow. Therefore, the devices are substantially equivalent in the consideration of intended use and Indications for Use.
Further, the devices are highly consistent with respect to technological characteristics. Both devices have the same compatible implant platforms, titanium (Ti)-base material, abutment fixation, maximum abutment angulation, surface treatment, and abutment packaging.
There are technological differences (i.e., connection interface, abutment design, wall thickness circular/margin, abutment width, design workflow, manufacturing workflow, surface topography, surface preservation, and sterilization) between the UA N1 and Reference #1, however, these differences do not affect the shared intended use, between the devices, nor raise different questions of substantial equivalence as demonstrated by non-clinical testing.
Temporary Abutments
The Temporary Abutments have the same intended use as the Healing Abutment Conical Connection WP and Temporary Snap Abutment Engaging Conical Connection WP from NobelActive Wide Platform (WP) - K133731 (Reference #2), as both abutment devices are premanufactured prosthetic components directly connected to an endosseous dental implant and or abutment base and is intended for use as an aid in prosthetic rehabilitation. In addition, the Indications for Use of the Temporary Abutments are similar to Reference #2 as both devices use similar wording. Temporary Abutments also include references to implant duration and digital workflows are represented in the Indications for Use of the On1 IOS Healing Cap from On1 Universal Abutment – K181869 (Reference #6) which has the same intended use as the Temporary Abutments and Reference #2. Therefore, the devices are substantially equivalent in the consideration of intended use and Indications for Use.
Further, the devices are highly consistent with respect to technological characteristics. Both devices have the same abutment diameter range, abutment angulation, packaging, and sterilization characteristics.
There are technological differences (i.e., material, post and gingival height, compatible implant platform, connection interface, and surface treatment) between the Temporary Abutments and Reference #2, however, these differences do not affect the shared intended use, between the devices, nor raise different questions of substantial equivalence as demonstrated by non-clinical bench testing.
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Screws
The Screws have the same intended use as the On1™ Clinical Screw, and On1™ Prosthetic Screw from On1 Concept – K161655 (Reference #3), as they are all screws intended to secure dental abutments to dental implants, dental abutments to dental abutments, or dental abutments to final restoration. In addition, the Indications for Use are similar to Reference #3 and the same as the Clinical Screws MUA from Multi-unit Abutment Plus - K 161416 (Reference #7). The differences between the indications are a choice of similar wording. The differences do not affect the shared intended use between the devices. Therefore, the devices are substantially equivalent in the consideration of intended use and Indications for Use.
Further, the devices are highly consistent with respect to technological characteristics. Both devices have the same material, range of surface treatments, range of anatomical sites, packaging, and sterilization parameters.
There are technological differences (i.e., shaft diameter, total length, connection interface, abutment compatibility) between the Screws and Reference #3, however, these differences do not affect the shared intended use, between the devices, nor raise different questions of substantial equivalence as demonstrated by non-clinical testing.
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Substantial Equivalence Tables
| Substantial Equivalence Table for N1 TiUltra TCC implants | ||||
|---|---|---|---|---|
| Subject Device | Predicate Device | Reference Device | ||
| TechnologicalCharacteristics | N1™ TiUltra™ TCC Implantsystem | NobelActive - K142260 (PrimaryPredicate) | TiUltra Implants and XealAbutments - K202344 (Reference#1) | Comparison |
| Device | Nobel Biocare N1™ TiUltra™ TCCimplants | NobelActive implants | NobelActive® TiUltra™ | |
| Pictorial Representation | Image: Nobel Biocare N1 TiUltra TCC implants | Image: NobelActive implants | Image: NobelActive TiUltra | -- |
| Regulatory Number/ DeviceClassification Name | 21 CFR§872.3640Endosseous dental implant | 21 CFR§872.3640Endosseous dental implant | 21 CFR§872.3640Endosseous dental implant | Same as the Primary Predicate. |
| Product Code | DZE | DZE | DZE | Same as the Primary Predicate. |
| Intended Use | Intended for use in the maxilla ormandible for supporting dentalprostheses to restore patientesthetics and chewing function. | NobelActive® implants areendosseous implants intended to besurgically placed in the upper orlower jaw bone for anchoring orsupporting tooth replacements torestore patient esthetics and chewingfunction. | Nobel Biocare's TiUltra implants arethreaded, root-form dental implantsintended for use in the upper and/orlower jaw to support prostheticdevices, such as artificial teeth, inorder to restore patient esthetics andchewing function to partially or fullyedentulous patients. | The same intended use as the PrimaryPredicate expressed through a similarchoice of words. |
| Indications for Use | N1™ TiUltra™ TCC Implant systemis indicated for use in the maxilla ormandible for anchoring orsupporting prosthetic teeth, in orderto restore patient esthetics andchewing function. N1™ TiUltra™TCC Implant system is indicatedfor single or multiple unitrestorations in splinted or non-splinted applications using a 2-stage | NobelActive® implants areendosseous implants intended to besurgically placed in the upper orlower jaw bone for anchoring orsupporting tooth replacements torestore patient esthetics and chewingfunction.NobelActive® implants are indicatedfor single or multiple unitrestorations in splinted or | NobelActive TiUltra implants areendosseous implants intended to besurgically placed in the upper orlower jaw bone for anchoring orsupporting tooth replacements torestore patient esthetics and chewingfunction.NobelActive TiUltra implants areindicated for single or multiple unitrestorations in splinted or | Similar Indications for Use as thePrimary Predicate expressed through asimilar choice of words. |
| Substantial Equivalence Table for N1 TiUltra TCC implants | ||||
| Subject Device | Predicate Device | Reference Device | ||
| TechnologicalCharacteristics | N1TM TiUltraTM TCC Implantsystem | NobelActive - K142260 (PrimaryPredicate) | TiUltra Implants and XealAbutments - K202344 (Reference#1) | Comparison |
| or 1-stage surgical technique incombination with immediate, earlyor delayed loading protocols, giventhat sufficient primary stability andappropriate occlusal loading for theselected technique has beenachieved. | non-splinted applications. This canbe achieved by a 2-stage or 1-stagesurgical technique in combinationwith immediate, early or delayedloading protocols, recognizingsufficient primary stability andappropriate occlusal loading for theselected technique.NobelActive® 3.0 implants areintended to replace a lateral incisor inthe maxilla and/or a central or lateralincisor in the mandible.NobelActive® 3.0 implants areindicated for single unit restorationsonly. | non-splinted applications. This canbe achieved by a 2-stage or 1-stagesurgical technique in combinationwith immediate, early or delayedloading protocols, recognizingsufficient primary stability andappropriate occlusal loading for theselected technique.NobelActive TiUltra 3.0 implants areintended to replace a lateral incisor inthe maxilla and/or a central or lateralincisor in the mandible.NobelActive TiUltra 3.0 implants areindicated for single-unit restorationsonly. | ||
| Implant Length | 7.0, 9.0, 11.0, 13.0 mm | 7.0, 8.5, 10.0, 11.5, 13.0, 15.0, 18.0mm | 7.0, 8.5, 10.0, 11.5, 13.0, 15.0, 18.0mm | The range of implant lengths fallswithin that of the Primary Predicate. |
| Implant Diameter | 3.5, 4.0 mm | 3.0, 3.5, 4.3, 5.0, 5.5 mm | 3.0, 3.5, 4.3, 5.0, 5.5 mm | The range of implant diameters fallswithin that of the Primary Predicate. |
| Platform Compatibility | Narrow Platform (NP)Regular Platform (RP) | 3.0 PlatformNarrow Platform (NP)Regular Platform (RP)Wide Platform (WP) | 3.0 PlatformNarrow Platform (NP)Regular Platform (RP)Wide Platform (WP) | The range of implant platforms fallswithin that of the Primary Predicate. |
| Connection Interface | Nobel Biocare Tri-oval ConicalConnection (TCC) | Nobel Biocare Internal ConicalConnection (CC) | Nobel Biocare Internal ConicalConnection (CC) | Serves the same function as thePrimary Predicate's connectioninterface. The differences do not raisedifferent questions of substantialequivalence and is substantiatedthrough fatigue testing. |
| Macro Design | Tapered implant with coronal tri-oval macro shape, cutting flutes andsingle lead threads | Tapered implant with back-taperedcoronal design, apical reverse-cuttingflutes and double lead threads | Tapered implant with back-taperedcoronal design, apical reverse-cuttingflutes and double lead threads | Serves the same function as thePrimary Predicate's macro design.The differences do not raise differentquestions of substantial equivalence,as demonstrated by torque testing. |
| TechnologicalCharacteristics | Subject Device | Predicate Device | Reference Device | Comparison |
| Material | N1™ TiUltra™ TCC Implantsystem | NobelActive - K142260 (PrimaryPredicate) | TiUltra Implants and XealAbutments - K202344 (Reference#1) | |
| Commercially pure titanium (grade4) according to ASTM F67 | Commercially pure titanium (grade4) according to ASTM F67 | Commercially pure titanium (grade4) according to ASTM F67 | Same as the Primary Predicate. | |
| Surface Treatment | Anodic oxidation | Machined on collar and inside theconnection (NP and RP)Anodic oxidation on collar and insidethe connection (WP) | Anodic oxidation | Same as the Primary Predicate's WPplatform implant. |
| Surface Topography | TiUltra - Three level surface:Level 0 (collar):Sa (area roughness) =0.5 ± 0.3 $ μ $ mThickness (Thk) =0.166 ± 0.008 $ μ $ mLevel 1 (transition):Sa = 0.8 ± 0.3 $ μ $ mThk = 7.5 ± 0.3 $ μ $ mLevel 2 (body):Sa = 1.5 ± 0.4 $ μ $ mThk = 12.0 ± 1.2 µm | TiUnite – Single level surface:Sa = 1.2 ± 0.5 $ μ $ mThk = 12.5 ± 2.5 $ μ $ m | TiUltra - Three level surface:Level 0 (collar):Sa (area roughness) =0.5 ± 0.3 $ μ $ mThickness (Thk) =0.166 ± 0.008 $ μ $ mLevel 1 (transition):Sa = 0.8 ± 0.3 $ μ $ mThk = 7.5 ± 0.3 $ μ $ mLevel 2 (body):Sa = 1.5 ± 0.4 $ μ $ mThk = 12.0 ± 1.2 $ μ $ m | Same as reference device (Reference#1). The differences do not raisedifferent questions of substantialequivalence, as demonstrated byfatigue and biocompatibility testing. |
| Surface Preservation | Soluble salt (protective) layer:Sodium dihydrogen phosphatedihydrate and magnesium chloridehexahydrate salt | None | Soluble salt (protective) layer:Sodium dihydrogen phosphatedihydrate and magnesium chloridehexahydrate salt | Same as reference device (Reference#1). The differences do not raisedifferent questions of substantialequivalence, as demonstrated byfatigue, biocompatibility, andpackaging and sterilization testing. |
| Substantial Equivalence Table for N1 TiUltra TCC implants | ||||
| Subject Device | Predicate Device | Reference Device | ||
| TechnologicalCharacteristics | N1™ TiUltra™ TCC Implantsystem | NobelActive – K142260 (PrimaryPredicate) | TiUltra Implants and XealAbutments - K202344 (Reference#1) | Comparison |
| Instructions for Use (DrillProtocol) | Two to four Step Drill ProtocolImage: N1 Drill Protocol | One to six Step Drill ProtocolImage: NobelActive Drill Protocol | N/A - The ISP protocol used for thisdevice is the same as K142260. | The Drill Protocol is similar to thePrimary Predicate and Reference #1.The differences do not raise differentquestions of substantial equivalence,as demonstrated by heat generationtesting, torque insertion testing, andperformance data from animal andclinical studies. |
| Packaging | N1 TiUltra TCC implants are co-packaged with the correspondingOsseoShaper 1 Nobel Biocare N1™in a polyethylene terephthalateglycol (PETG) Blister tray heatsealed with a Tyvek® lid (sterilebarrier) inside a cardboard box(protective packaging). | Polyethylene terephthalate (PET) vialwith high density polyethylene(HDPE) cap (1st sterile barrier)placed in a polyethyleneterephthalate glycol (PETG) blistertray heat sealed with a Tyvek® lid(2nd sterile barrier) inside a cardboardbox (protective packaging). | Polyethylene terephthalate (PET)vial with high density polyethylene(HDPE) cap (1st sterile barrier)placed in a polyethyleneterephthalate glycol (PETG) blistertray heat sealed with a Tyvek® lid(2nd sterile barrier) inside a cardboardbox (protective packaging | N1 TiUltra TCC implants have similarpackaging to the Primary Predicate.The differences do not raise differentquestions of substantial equivalence asdemonstrated by packaging validation. |
| Sterilization | Gamma sterilization (SAL 10-6) | Gamma sterilization (SAL 10-6) | Gamma sterilization (SAL 10-6) | Same as the Primary Predicate. |
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| Substantial Equivalence Table for the Cover Screw | ||||
|---|---|---|---|---|
| Subject Device | Predicate Device | Reference Device | ||
| Technological | N1™ TiUltra™ TCC Implant | NobelActive - K142260 (Primary | On1 Concept – K161655 | |
| Characteristics | system | Predicate) | (Reference #3) | Comparison |
| Device | Cover Screw Nobel Biocare N1™TCC | Cover screws | On1 Clinical Screw | -- |
| Pictorial Representation | Image: N1 TiUltra TCC Implant system | Image: NobelActive - K142260 (Primary Predicate) | Image: On1 Concept – K161655 (Reference #3) | -- |
| Regulatory Number /Device Classification Name | 21 CFR§872.3640Endosseous dental implant | 21 CFR§872.3640Endosseous dental implant | 21 CFR§872.3630Endosseous dental implantabutment | Same as the Primary Predicate. |
| Product Code | DZE | DZE | NHA | Same as the Primary Predicate. |
| Intended Use | Dental implant Cover Screws are tobe used in the upper or lower jawconnected to the endosseousimplant to protect the internalthreads and implant head during thehealing phase. | Intended to be temporarilyconnected to an endosseous dentalimplant to protect the implantconnection interface during bonehealing. | Intended for fixation of the On1Base. | The same intended use as the PrimaryPredicate expressed through a similarchoice of words. |
| Indications for Use | To be used when applicabletogether with the implant duringhealing in order to protect theimplant platform and internalthreads from overgrowth of bone. | Cover screws are indicated for usewith implants placed in the maxilla,mandible, or zygomatic bone, as perthe indications for the respectiveimplant system. | The On1™ device is apremanufactured prostheticcomponent directly connected to anendosseous implant and it isintended for use in prostheticrehabilitation. | Similar Indications for Use as thePrimary Predicate expressed through asimilar choice of words. |
| Design | 2-piece pre-assembled | 1-piece | 1-piece | Serves the same function as thePrimary Predicate. Provided pre-assembled into 1-piece. Thedifferences do not raise differentquestions of substantial equivalence. |
| Diameter | 3.2, 3.4 mm | 3.0, 3.5, 3.9, 5.1 mm | 1.185, 1.475 mm | The range of cover screw diametersfalls within that of the PrimaryPredicate. |
| Gingival Height | 0.4 mm | 0.4 mm | -- | Same as the Primary Predicate. |
| Substantial Equivalence Table for the Cover Screw | ||||
| TechnologicalCharacteristics | Subject DeviceN1™ TiUltra™ TCC Implantsvstem | Predicate DeviceNobelActive - K142260 (PrimaryPredicate) | Reference DeviceOn1 Concept - K161655(Reference #3) | Comparison |
| Connection Interface | Nobel Biocare Tri-oval ConicalConnection (TCC) | Nobel Biocare Internal ConicalConnection (CC) | Nobel Biocare Internal ConicalConnection (CC) | Serves the same function as thePrimary Predicate's connectioninterface. The differences do not raisedifferent questions of substantialequivalence. |
| Surface treatment | AnodizationDLC Coating (screw interface) | Anodization | AnodizationDLC Coating (screw interface) | Similar to the Primary Predicate andreference device (Reference #3). Thedifferences do not raise differentquestions of substantial equivalence. |
| Material | Titanium-aluminum-vanadiumalloy(ASTM F136 and ISO 5832-3) | Titanium-aluminum-vanadiumalloy(ASTM F136 and ISO 5832-3) | Titanium-aluminum-vanadiumalloy(ASTM F136 and ISO 5832-3) | Same as Primary Predicate |
| Packaging | Thermoformed PETG blister trayand sealed with a peelable medicalpaper lid | Thermoformed PETG blister trayand sealed with a peelable medicalpaper lid | Thermoformed PETG blister trayand sealed with a peelable medicalpaper lid | Same as the Primary Predicate. |
| Sterilization | Gamma sterilization (SAL 10-6) | Gamma sterilization (SAL 10-6) | Gamma sterilization (SAL 10-6) | Same as the Primary Predicate. |
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| Substantial Equivalence OsseoShapers | |||||
|---|---|---|---|---|---|
| Subject Device | Predicate Device | Reference Device | |||
| TechnologicalCharacteristics | N1™ TiUltra™ TCC Implant system | NobelActive(K142260 - Primary Predicate) | Branemark Novum(K000018 - Reference #4) | Comparison | |
| Device | OsseoShaper 1 Nobel Biocare N1™OsseoShaper 2 Nobel Biocare N1™ | Screw Tap | Screw Tap ø5mm | -- | |
| Graphic Illustration | OsseoShaper 1 Nobel Biocare N1™Image: [OsseoShaper 1 Nobel Biocare N1]OsseoShaper 2Image: [OsseoShaper 2] | Image: [ACT 3.5 and ACT 4.3] | Image: [Branemark Novum] | -- | |
| Regulatory Number/Device ClassificationName | 21 CFR§872.3980Endosseous dental implant accessories | 21 CFR§872.3640Endosseous dental implant | 21 CFR§872.3640Endosseous dental implant | Similar classifications as per FDA interactions. | |
| Product Code | QRQ | DZE | DZE | ||
| Intended Use | The N1™ system Implant SitePreparation Tools are used to cut intothe maxilla or mandible to create anosteotomy for endosseous dentalimplant placement. | Intended for use to prepare or supportthe preparation of an osteotomy forplacement of an endosseous dentalimplant. | -- | The same intended use as the PrimaryPredicate expressed through a similar choice ofwords. | |
| Indications for Use | The N1™ system Implant SitePreparation Tools are indicated to beused in the maxilla or mandible toprepare an osteotomy prior toplacement of a Nobel Biocare N1™TiUltra™ TCC implant. | 510k cleared Indications for Use:NobelActive® implants are endosseousimplants intended to be surgicallyplaced in the upper or lower jaw bonefor anchoring or supporting toothreplacements to restore patientesthetics and chewing function.NobelActive® implants are indicatedfor single or multiple unit restorationsin splinted or non-splintedapplications. This can be achieved bya 2-stage or 1-stage surgical techniquein combination with immediate, earlyor delayed loading protocols,recognizing sufficient primary stability | 510(k) cleared Indications for Use:Totally edentulous mandibles with aminimum height of 13mm and aminimum width of 6mm. Patientmust be subject to dental treatmentwith endosseous implants. For use ina single stage procedure where theimplants are immediately loaded. | Similar Indications for Use as the PrimaryPredicate expressed through a similar choice ofwords. | |
| Substantial Equivalence OsseoShapers | |||||
| TechnologicalCharacteristics | Subject Device | Predicate Device | Reference Device | Comparison | |
| N1™ TiUltra™ TCC Implant system | NobelActive(K142260 - Primary Predicate) | Branemark Novum(K000018 - Reference #4) | |||
| and appropriate occlusal loading forthe selected technique.NobelActive® 3.0 implants areintended to replace a lateral incisor inthe maxilla and/or a central or lateralincisor in the mandible.NobelActive® 3.0 implants areindicated for single unit restorationsonly.The Screw Tap used with the ImplantSystem:Screw Taps NobelActive are indicatedfor use in the maxilla or mandible toprepare an osteotomy in dense bonefor placement of NobelActive®TiUnite™ Implants. | |||||
| Anatomical Site | Narrow Platform (NP)Regular Platform (RP) | Narrow Platform (NP)Regular Platform (RP) | -- | Same as Primary Predicate. | |
| Design | MaximumDiameter | OsseoShaper 1 Nobel Biocare N1™:ø3.9 mmOsseoShaper 2 Nobel BiocareN1™:ø4.4 mm | NP – ø3.54 mmRP – ø4.3 mm | ø4.9 mm | The maximum diameter is within the range ofthe Primary Predicate and K000018 –Reference #4. The differences do not raisedifferent questions of substantial equivalence,as demonstrated through heat generationtesting. |
| Flute InsertionLength | NP – 9.5, 11.5, 13.5 mmRP – 7.5, 9.5, 11.5, 13.5 mm | NP – 8.2 mmRP – 8.4 mm | 15.5 mm | The flute length range is similar to the range ofthe Primary Predicate and K000018 –Reference #4. The differences do not raisedifferent questions of substantial equivalence,as demonstrated through heat generationtesting. | |
| Flute Design | 3 flutes (helical) | 4 flutes (straight) | 3 flutes (straight) | The flute design is similar to K000018 –Reference #4. The differences do not raisedifferent questions of substantial equivalence,as demonstrated through heat generationtesting. | |
| Substantial Equivalence OsseoShapers | |||||
| TechnologicalCharacteristics | Subject DeviceN1™ TiUltra™ TCC Implant system | Predicate DeviceNobelActive(K142260 - Primary Predicate) | Reference DeviceBranemark Novum(K000018 - Reference #4) | Comparison | |
| Tip design | 180° Flat | 180° Flat | 180° Flat | Same as the Primary Predicate and K000018 – Reference #4. | |
| Material | Titanium-aluminum-vanadium alloy(ASTM F136, ISO 5832-3) | Stainless Steel (ASTM F899) | Unalloyed Titanium (ASTM F67-95) | Similar to K000018 – Reference #4. Thedifferences do not raise different questions ofsubstantial equivalence, as demonstratedthrough heat generation testing andbiocompatibility evaluation. | |
| Surface Treatment | OsseoShaper 1 Nobel Biocare N1™:NoneOsseoShaper 2 Nobel Biocare N1™:Anodization | Screw Tap: DLC coatingNobelActive Implants: Anodization | -- | The differences in surface treatment do notraise different questions of substantialequivalence, as demonstrated through heatgeneration testing and biocompatibilityevaluation. | |
| HandpieceConnection | ISO 1797 Type 1ISO 17509 | ISO 1797 Type 1 | 2.4 mm square | The connection which is compatible with ISO1797 Type 1 is shared with the PrimaryPredicate. The OsseoShapers offer anadditional compatibility to ISO 17509. Thedifferences do not raise different questions ofsubstantial equivalence, as demonstratedthrough heat generation testing. | |
| Markings | Yes | Yes | -- | Same as Primary Predicate | |
| Drill Speed | Maximum 50 rpm | Maximum 25 rpm | -- | The drill speed is similar to the PrimaryPredicate. The differences do not raisedifferent questions of substantial equivalenceand is demonstrated through heat generationtesting. | |
| Irrigation | No irrigation | No irrigation | No irrigation | Same as Primary Predicate. | |
| Duration of Use | Transient use during surgery | Transient use during surgery | Transient use during surgery | Same as Primary Predicate. | |
| Reusability | Single use | Reusable | Single use | Same as K000018 – Reference #4. Thereusability differences of the OsseoShapers donot raise different questions of substantialequivalence as single use products have lessassociated sterility risks than reusable productsand sterilization validation was performed. | |
| Substantial Equivalence OsseoShapers | |||||
| Subject Device | Predicate Device | Reference Device | |||
| TechnologicalCharacteristics | N1™ TiUltra™ TCC Implant system | NobelActive(K142260 - Primary Predicate) | Branemark Novum(K000018 - Reference #4) | Comparison | |
| Packaging | OsseoShaper 1 Nobel Biocare N1™:Co-packaged with correspondingimplant in a polyethylene terephthalateglycol (PETG) Blister tray heat sealedwith a Tyvek® lid (sterile barrier) insidea cardboard box (protective packaging)or single packed in sterile blister | Sterile blister | Sterile blister | Similar to the Primary Predicate. Thedifferences do not raise different questions ofsubstantial equivalence as demonstrated bypackaging validation. | |
| OsseoShaper 1 Nobel Biocare N1 andOsseoShaper 2 Nobel Biocare N1™:Single packed in sterile blister | |||||
| Sterilization | Gamma sterilization (SAL 10-6) | Gamma sterilization (SAL 10-6) | Gamma sterilization (SAL 10-6) | Same |
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| Substantial Equivalence Multi-unit Abutment Xeal™ Nobel Biocare N1™ TCC | ||||
|---|---|---|---|---|
| Subject Device | Predicate Device | |||
| Technological Characteristics | N1™ TiUltra™ TCC Implant system | TiUltra Implants and Xeal Abutments(K202344 - Reference #1) | Comparison | |
| Device | Multi-unit Abutment Xeal Nobel Biocare N1™ TCC | Multi-unit Abutment (MUA) Xeal™ | -- | |
| Pictorial Representation | Image: Subject Device | Image: Predicate Device | -- | |
| Regulatory Number/ DeviceClassification Name | 21 CFR§872.3630Endosseous dental implant abutment | 21 CFR§872.3630Endosseous dental implant abutment | Same as Reference #1. | |
| Product Code | NHA | NHA | Same as Reference #1. | |
| Intended Use | Dental implant abutments are intended to be usedin the upper or lower jaw and used for supportingtooth replacements to restore chewing function.Multi-unit Abutments TCC in combination withendosseous implants are indicated for multiple unitreconstructions when screw retained prosthetics ispreferred. | MUA Xeal in combination with endosseousimplants are intended for multiple unitreconstructions when screw retained prosthetics ispreferred. | Same intended use as Reference #1andexpressed with similar wording. | |
| Indications for Use | Multi-unit Abutment TCC is a premanufacturedprosthetic component directly connected to theendosseous dental implant and is intended for useas an aid in prosthetic rehabilitation. | The MUA Xeal is a pre-manufactured prostheticcomponent directly connected to the endosseousdental implant and is intended for use as an aid inprosthetic rehabilitation. | Same as Reference #1. | |
| Design Features | Compatible Implants Platforms | Narrow Platform (NP)Regular Platform (RP) | 3.0 PlatformNarrow Platform (NP)Regular Platform (RP)Wide Platform (WP) | Same platforms are used within Reference#1. |
| Connection Interface | Nobel Biocare Tri-oval Conical Connection (TCC) | Nobel Biocare Conical Connection (CC) | Similar to Reference #1. The differencesdo not raise different questions ofsubstantial equivalence as demonstrated bythe fatigue testing. | |
| Substantial Equivalence Multi-unit Abutment Xeal™ Nobel Biocare N1™ TCC | ||||
| Subject Device | Predicate Device | |||
| N1™ TiUltra™ TCC Implant system | TiUltra Implants and Xeal Abutments(K202344 - Reference #1) | |||
| Technological Characteristics | Comparison | |||
| Abutment Height | Straight: 1.5, 2.5, 3.5, 4.5 mmAngulated 17°: 2.5, 3.5 mmAngulated 30°: 3.5, 4.5 mm | Straight: 1.5, 2.5, 3.5, 4.5 mmAngulated 17°: 2.5, 3.5 mmAngulated 30°: 3.5, 4.5 mm | Same as Reference #1. | |
| Abutment Width | 4.8 mm | 4.8 mm | Same as Reference #1. | |
| Abutment Angulation | 0°, 17°, 30° | 0°, 17°, 30° | Same as Reference #1. | |
| Material | Titanium-aluminum-vanadium alloy(ASTM F136, ISO 5832-3) | Titanium-aluminum-vanadium alloy(ASTM F136, ISO 5832-3) | Same as Reference #1. | |
| SurfaceTreatment | Anodization | Anodization | Same as Reference #1. | |
| Abutment SurfaceTopography | Xeal – Single level surfaceSa <0.8 µm | Xeal – Single level surfaceSa <0.8 µm | Same as Reference #1. | |
| Surface Preservation | Soluble salt (protective) layer: Sodium dihydrogenphosphate dihydrate and magnesium chloridehexahydrate salt | Soluble salt (protective) layer: Sodium dihydrogenphosphate dihydrate and magnesium chloridehexahydrate salt | Same as Reference #1. | |
| Packaging | Thermoformed polyethylene terephthalate glycol(PETG) blister tray with medical paper lid forminga sterile barrier | Thermoformed polyethylene terephthalate glycol(PETG) blister tray with medical paper lid forminga sterile barrier | Same as Reference #1. | |
| Sterilization | Gamma sterilization (SAL 10-6) | Gamma sterilization (SAL 10-6) | Same as Reference #1. |
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| Substantial Equivalence Universal Abutments | ||||
|---|---|---|---|---|
| Technologicalcharacteristics | Subject DeviceN1™ TiUltra™ TCC Implant system | Predicate DeviceTiUltra Implants and Xeal Abutments(K202344 - Reference #1) | Reference DeviceUniversal Base Conical Connection(CC)(K200040 - Reference #5) | Comparison |
| Device | Universal Abutment Nobel Biocare N1™ TCCNobel Biocare N1™ Base Xeal™ TCC TriUniversal Abutment Nobel Biocare N1™ Base TriUniversal Abutment Nobel Biocare N1™ Base Tri (Bridge) | On1 Base Xeal™Multi-unit Abutment Xeal™ | Universal Base Conical Connection (CC) | -- |
| Pictorial Representation | Universal Abutment Nobel Biocare N1™ TCCImage: Universal Abutment Nobel Biocare N1 TCC | Universal Base Conical ConnectionImage: Universal Base Conical Connection | -- | |
| Nobel Biocare N1™ Base Xeal™ TCC TriImage: Nobel Biocare N1 Base Xeal TCC Tri | On1 Base XealImage: On1 Base Xeal | |||
| Universal Abutment Nobel Biocare N1™ Base TriImage: Universal Abutment Nobel Biocare N1 Base Tri | On1 Universal Abutment(indicated with the On1 Base Xeal)Image: On1 Universal Abutment | |||
| Substantial Equivalence Universal Abutments | ||||
| Technological characteristics | Subject DeviceN1™ TiUltra™ TCC Implant system | Predicate DeviceTiUltra Implants and Xeal Abutments(K202344 – Reference #1) | Reference DeviceUniversal Base Conical Connection(CC)(K200040 – Reference #5) | Comparison |
| Image: Universal Abutment Nobel Biocare N1™ Base Tri (Bridge) | Image: Multi-unit Abutment (MUA) Xeal [straight, 0°] | |||
| Regulatory Number/ DeviceClassification Name | 21 CFR§872.3630Endosseous dental implant abutment | 21 CFR§872.3630Endosseous dental implant abutment | 21 CFR§872.3630Endosseous dental implant abutment | Same as Reference #1. |
| Product Code | NHA | NHA | NHA | Same as Reference #1. |
| Subsequent Product Code | PNP | PNP | PNP | Same as Reference #1. |
| Intended Use | Intended to be connected to anendosseous dental implant to supportthe placement of a dental prosthesis. | The On1 Base Xeal™ is intended for usein the field of dentistry. It is intended tobe used in the upper or lower jaw forsupporting tooth replacements to restorechewing function and esthetics.The On1 Base Xeal™ on Nobel BiocareConical Connection endosseousimplants are indicated for single-unitcement retained restorations.MUA Xeal™ in combination withendosseous implants are intended formultiple unit reconstructions whenscrew retained prosthetics is preferred. | The Universal Base ConicalConnection are attached to NobelBiocare dental implants and areintended to support a crown. | Same intended use asReference #1 andexpressed with similarwording. |
| Substantial Equivalence Universal Abutments | ||||
| Technologicalcharacteristics | Subject DeviceN1™ TiUltra™ TCC Implant system | Predicate DeviceTiUltra Implants and Xeal Abutments(K202344 - Reference #1) | Reference DeviceUniversal Base Conical Connection(CC)(K200040 - Reference #5) | Comparison |
| Indication for Use | Universal Abutment Nobel Biocare N1™TCCUniversal abutments are indicated tosupport the placement of single unit,screw- retained prosthetic restorations inthe maxilla or mandible.The Universal Abutment consists of twomajor parts. Specifically, the titaniumbase and mesostructure componentsmake up a two-piece abutment.The system integrates multiplecomponents of the digital dentistryworkflow scan files from Intra-OralScanners, CAD software, CAMsoftware, ceramic material, millingmachine and associated tooling andaccessories. | The On1 Base Xeal™ device is apremanufactured prosthetic componentdirectly connected to an endosseousimplant and it is intended for use inprosthetic rehabilitation.The On1 Universal Abutments consistof three major parts. Specifically, theOn1 Base Xeal, the On1 UniversalAbutment, and the mesostructurecomponents make up a multi-pieceabutment.The system integrates multiplecomponents of the digital dentistryworkflow scan files from Intra-OralScanners, CAD software, CAMsoftware, ceramic material, millingmachine and associated tooling andaccessories.The MUA Xeal™ is a premanufacturedprosthetic component directly connectedto the endosseous dental implant and isintended for use as an aid in prostheticrehabilitation. | The Universal Base ConicalConnection is a premanufacturedprosthetic component directlyconnected to endosseous dentalimplants and is intended for use asan aid in prosthetic rehabilitation.The Universal Base ConicalConnection consists of two majorparts. Specifically, the titanium baseand mesostructure componentsmake up a two-piece abutment.The system integrates multiplecomponents of the digital dentistryworkflow scan files from Intra-OralScanners, CAD software, CAMsoftware, ceramic material, millingmachine and associated tooling andaccessories. | Similar to Reference #1and Reference #5. TheIndications for Use areexpressed through asimilar of words. |
| The Universal Abutment Nobel BiocareN1™ Base consist of three major parts.Specifically, the N1 Base Xeal, theUniversal Abutment N1 Base, and themesostructure components make up amulti-piece abutment. The systemintegrates multiple components of thedigital dentistry workflow scan filesfrom Intra-Oral Scanners, CADsoftware, CAM software, ceramicmaterial, milling machine andassociated tooling and accessories. | ||||
| Substantial Equivalence Universal Abutments | ||||
| Technologicalcharacteristics | Subject Device | Predicate Device | Reference Device | Comparison |
| N1™ TiUltra™ TCC Implant system | TiUltra Implants and Xeal Abutments(K202344 – Reference #1) | Universal Base Conical Connection (CC)(K200040 – Reference #5) | ||
| Nobel Biocare N1™ Base Xeal™The Nobel Biocare N1™ Base Xeal™ isindicated for use in the maxilla ormandible for supporting toothreplacements to restore chewingfunction. It is indicated for single unitrestorations and multiple unitrestorations up to 6 units with less than20° divergence to allow path ofinsertion.Universal Abutment Nobel Biocare N1™Base TriThe Universal Abutment Nobel BiocareN1™ Base Tri is indicated to support theplacement of single unit, screw-retainedprosthetic restorations in the maxilla ormandible.Universal Abutment Nobel Biocare N1™Base Tri BridgeThe Universal Abutment Nobel BiocareN1™ Base Tri Bridge is indicated tosupport the placement of multiple unitof up to 6 units, screw-retainedprosthetic restorations in the maxilla ormandible for implants with less than 20°overall divergences to allow path ofinsertion. | ||||
| DesignFeatureCompatible ImplantsPlatforms | Narrow Platform (NP) Regular Platform (RP) | Narrow Platform (NP) Regular Platform (RP) Wide Platform (WP) | Narrow Platform (NP) Regular Platform (RP) Wide Platform (WP) | The same platforms areused for Reference#1and Reference #5. |
| Substantial Equivalence Universal Abutments | ||||
| Technologicalcharacteristics | Subject DeviceN1™ TiUltra™ TCC Implant system | Predicate DeviceTiUltra Implants and Xeal Abutments(K202344 - Reference #1) | Reference DeviceUniversal Base Conical Connection(CC)(K200040 - Reference #5) | Comparison |
| Connection Interface | UniversalAbutment NobelBiocare N1 TCCNobel BiocareN1™ Base XealTCC TriUniversalAbutment NobelBiocare N1 BaseTri | Nobel Biocare Internal ConicalConnection | Nobel Biocare Internal ConicalConnection | The UA N1 havesimilarly designedconnection interfacesand the purpose of theconnection interface isthe same. Thedifferences do not raisedifferent questions ofsubstantial equivalenceas demonstrated byfatigue testing. |
| UniversalAbutment NobelBiocare N1 BaseTri (Bridge) | Nobel BiocareTri-oval ConicalConnection (TCC)Nobel BiocareTri-oval ConicalConnection (TCC)Nobel Biocare N1Base ConnectionNobel Biocare N1Base Connection | |||
| Ti-base Material | Titanium-aluminum-vanadium alloy(ASTM F136 and ISO 5832-3) | Titanium-aluminum-vanadium alloy(ASTM F136 and ISO 5832-3) | Titanium-aluminum-vanadium alloy(ASTM F136 and ISO 5832-3) | Same as Reference #1. |
| Mesostructure/CrownMaterial | ZirconiaNacera Pearl (K143071) DoceramMedical Ceramics GmbH | On1 Base Xeal with the On1 UniversalAbutmentVita Enamic IS (K153645) VitaZahnfabrik H. Rauter GmbH Co | Vita Enamic IS (K153645)Vita Zahnfabrik H. Rauter GmbHCo | Same as Reference #1,materials that arecleared formesostructure/crownfabrication. |
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| Substantial Equivalence Universal Abutments | ||||||
|---|---|---|---|---|---|---|
| Technologicalcharacteristics | Subject DeviceN1™ TiUltra™ TCC Implant system | Predicate DeviceTiUltra Implants and Xeal Abutments(K202344 - Reference #1) | Reference DeviceUniversal Base Conical Connection(CC)(K200040 - Reference #5) | Comparison | ||
| Abutment Design | UniversalAbutment NobelBiocare N1 TCC | 2-piece abutmentAbutmentpremanufacturedSingle-unit | On1 Base Xeal | 3-piece abutment.AbutmentpremanufacturedSingle Unit | 2-piece abutmentAbutment premanufacturedSingle unit | Universal AbutmentNobel Biocare N1™Base Tri, UniversalAbutment NobelBiocare N1™ Base Tri(Bridge), and NobelBiocare N1™ BaseXeal™ TCC Tri aresimilar to Reference #1.Universal Abutment |
| Nobel BiocareN1™ Base XealTCC Tri | 3-piece abutment.AbutmentpremanufacturedSingle-unit andMulti-unit | Multi-unitAbutment Xeal | 1-piece abutmentAbutmentpremanufacturedMulti-unit | Nobel Biocare N1™TCC is the same asReference #5.The differences do notraise differentquestions of substantial | ||
| UniversalAbutment NobelBiocare N1 BaseTri | 3-piece abutment.AbutmentpremanufacturedSingle-unit | equivalence, asdemonstrated byfatigue testing. | ||||
| UniversalAbutment NobelBiocare N1 BaseTri (Bridge) | 3-piece abutment.AbutmentpremanufacturedMulti-unit | |||||
| Abutment Fixation | Abutment fixation with a screw. | Abutment fixation with a screw. | Abutment fixation with a screw. | Same as Reference #1. | ||
| Maximum AbutmentAngulation | 20° | On1 Base Xeal with the On1 UniversalAbutment20° | 20° | Same as Reference #1. | ||
| Wall ThicknessCircular/ Margin(mesostructure) | Circular: 0.5 mmMargin: 0.35 mm | On1 Base Xeal with the On1 UniversalAbutmentCircular: 0.8 mm min.Margin: 0.275 mm min. | Circular: 0.8 mm min.Margin: 0.275 mm min. | Similar to Reference#1. The differences donot raise differentquestions of substantialequivalence, asdemonstrated byfatigue testing. | ||
| Post Height Minimum | 5.2 mm | On1 Base Xeal with the On1 UniversalAbutment | 5.2 mm min. | Same as Reference #1. | ||
| Substantial Equivalence Universal Abutments | ||||||
| Technologicalcharacteristics | Subject DeviceN1™ TiUltra™ TCC Implant system | Predicate DeviceTiUltra Implants and Xeal Abutments(K202344 – Reference #1) | Reference DeviceUniversal Base Conical Connection(CC)(K200040 – Reference #5) | Comparison | ||
| 5.2 mm min. | ||||||
| Abutment Height | Universal AbutmentNobel Biocare N1 TCC | 1.5, 3.0 mm | On1 Base Xeal1.75, 2.5 mm | 1.5, 3.0 mm | Abutment heights arewithin the range ofReference #1. | |
| Nobel Biocare N1 BaseXeal TCC Tri | 1.75, 2.5,3.5 mm | On1 UniversalAbutment0.3, 1.25 mm | ||||
| Universal AbutmentNobel Biocare N1 BaseTri | 4.5 mm | Multi-unitAbutment Xeal1.5, 2.5, 3.5, 4.5mm | ||||
| Universal AbutmentNobel Biocare N1 BaseTri (Bridge) | 4.5 mm | |||||
| Abutment Width | Universal AbutmentNobel Biocare N1 TCC | 4.5 mm | On1 Base Xeal4.8, 5.3, 6.5 mm | 4.775, 6.515 mm | Similar to Reference #1.The differences do notraise different questionsof substantialequivalence, asdemonstrated by fatiguetesting. | |
| Nobel Biocare N1 BaseXeal TCC Tri | 4.2, 4.5 mm | Multi-unitAbutment Xeal4.8 mm | ||||
| Universal AbutmentNobel Biocare N1 BaseTri | 4.8, 5.0 mm | |||||
| Universal AbutmentNobel Biocare N1 BaseTri (Bridge) | 4.8, 5.0mm | |||||
| Substantial Equivalence Universal Abutments | ||||||
| Technologicalcharacteristics | Subject DeviceN1™ TiUltra™ TCC Implant system | Predicate DeviceTiUltra Implants and Xeal Abutments(K202344 - Reference #1) | Reference DeviceUniversal Base Conical Connection(CC)(K200040 - Reference #5) | Comparison | ||
| Design Workflow | • ScannerKavo LS3, 3Shape Trios or otherscanners with equal or higheraccuracy than 6.9 µm• Design softwareDTX Studio Design (K181932, wherethe implant libraries are automaticallyincluded in the software installer) or3Shape Abutment Designer Software(K151455, where the implant librariesare obtained via the 3Shape server inthe software). | On1 Base Xeal with the On1 UniversalAbutment• Scanner: Trios intra oral scanner by3Shape A/S• Design Software: 3Shape AbutmentDesigner Software (K151455, wherethe implant libraries are obtained viathe 3Shape server in the software) | • Scanner Trios intra oral scannerby 3Shape A/SDesign Software 3Shape• Abutment Designer Software(K151455) | Similar to Reference #1and Reference #5. Thedifferences do not raisedifferent questions ofsubstantial equivalence,as demonstrated bymanufacturing softwareverification and End-to-End (E2E) validation. | ||
| ManufacturingWorkflow | Milling unit- Indicated for Zirconia milling- Minimum 5 axis milling technology- Minimum 30.000 rpm spindle speed | On1 Base Xeal with the On1 UniversalAbutmentMilling unitCORITEC by imes-icore | Milling unitCORITEC by imes-icore | Similar to Reference#1and Reference #5.The differences do notraise differentquestions of substantialequivalence, asdemonstrated by E2Evalidation. | ||
| Surface Treatment | Anodization | Anodization | None | Same as Reference #1. | ||
| Surface Topography | UniversalAbutment NobelBiocare N1 TCCNobel BiocareN1 Base XealTCC TriUniversalAbutment NobelBiocare N1 Base | Ra1 1.6 µm (TCCConnectionSa2<0.6 µm)Ra 0.8µm (TCCConnectionSa<0.6 µm)Ra 0.8 µm | Sa <0.8 µm | Ra 0.8 | Similar to Reference#1and Reference #5.The differences do notraise questions ofsubstantial equivalenceas demonstrated byfatigue testing andbiocompatibilitytesting. | |
| Substantial Equivalence Universal Abutments | ||||||
| Technologicalcharacteristics | Subject DeviceN1™ TiUltra™ TCC Implant system | Predicate DeviceTiUltra Implants and Xeal Abutments(K202344 – Reference #1) | Reference DeviceUniversal Base Conical Connection(CC)(K200040 – Reference #5) | Comparison | ||
| UniversalAbutment NobelBiocare N1 BaseTri (Bridge) | Ra 0.8 µm | |||||
| Surface Preservation | UniversalAbutment NobelBiocare N1 TCC | None | Soluble salt (protective) layer: Sodiumdihydrogen phosphate dihydrate andmagnesium chloride hexahydrate salt | None | Nobel Biocare N1™Base Xeal™ TCC Tri isthe same as Reference#1. | |
| Nobel BiocareN1 Base XealTCC Tri | Soluble salt(protective) layer:Sodiumdihydrogenphosphatedihydrate andmagnesiumchloridehexahydrate salt | Universal AbutmentNobel Biocare N1™TCC, UniversalAbutment NobelBiocare N1™ Base Triand Universal AbutmentNobel Biocare N1™Base Tri (Bridge) is thesame as Reference #5. | ||||
| UniversalAbutment NobelBiocare N1 BaseTri | None | The differences do notraise different questionsof substantialequivalence, as | ||||
| UniversalAbutment NobelBiocare N1 BaseTri (Bridge) | None | demonstrated bybiocompatibility testingand, packaging andsterilization validation. | ||||
| Packaging | Thermoformed polyethylene terephthalateglycol (PETG) blister tray with medicalpaper lid forming a sterile barrier. | Thermoformed polyethylene terephthalateglycol (PETG) blister tray with medicalpaper lid forming a sterile barrier. | Thermoformed polyethyleneterephthalate glycol (PETG) blistertray with medical paper lid forming asterile barrier. | Same as Reference #1. | ||
| Substantial Equivalence Universal Abutments | ||||||
| Technologicalcharacteristics | Subject DeviceN1™ TiUltra™ TCC Implant system | Predicate DeviceTiUltra Implants and Xeal Abutments(K202344 – Reference #1) | Reference DeviceUniversal Base Conical Connection(CC)(K200040 – Reference #5) | Comparison | ||
| Sterilization | UniversalAbutment NobelBiocare N1 TCC | Non-sterile, enduser sterilized | Gamma sterilization (SAL 10-6) | Non-sterile – end user sterilized | Similar to Reference#1and Reference #5.The differences do notraise different questionsof substantialequivalence, asdemonstrated bycleaning andsterilization validation. | |
| Nobel BiocareN1 Base XealTCC Tri | Gamma Radiation(SAL 10-6) | |||||
| UniversalAbutment NobelBiocare N1 BaseTri | Non-sterile, enduser sterilized | |||||
| UniversalAbutment NobelBiocare N1 BaseTri (Bridge) | Non-sterile, enduser sterilized |
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¹ Profile Roughness (Ra)
² Area Roughness (Sa)
^2 Area Roughness (Sa)
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| Substantial Equivalence Temporary Abutments | |||||
|---|---|---|---|---|---|
| Technologicalcharacteristics | Subject DeviceN1™ TiUltra™ TCC Implant system | Predicate DeviceNobelActive WidePlatform (WP) – K133731(Reference #2) | Reference DeviceOn1 Concept- K161655(Reference #3) | Reference DeviceOn1 Universal Abutment– K181869 (Reference #6) | Comparison |
| Device Name | Temporary Abutments | Healing Abutment ConicalConnection WPTemporary Snap AbutmentEngaging ConicalConnection WP | On1 Healing CapOn1 Temporary AbutmentEngaging | On1 IOS Healing Cap | -- |
| PictorialRepresentation | Healing Abutment Nobel BiocareN1™ TCCImage: Healing Abutment Nobel Biocare N1 TCC | Healing Abutment ConicalConnection WPImage: Healing Abutment Conical Connection WP | -- | ||
| Temporary Abutment Nobel BiocareN1™ TCCImage: Temporary Abutment Nobel Biocare N1 TCC | Temporary Snap AbutmentEngaging ConicalConnection WPImage: Temporary Snap Abutment Engaging Conical Connection WP | ||||
| Healing Abutment Nobel BiocareN1™ Base TriImage: Healing Abutment Nobel Biocare N1 Base Tri | On1 Healing CapImage: On1 Healing Cap | ||||
| Temporary Abutment Nobel BiocareN1™ Base TriImage: Temporary Abutment Nobel Biocare N1 Base Tri | On1 Temporary AbutmentEngagingImage: On1 Temporary Abutment Engaging | ||||
| Substantial Equivalence Temporary Abutments | |||||
| Subject Device | Predicate Device | Reference Device | Reference Device | Comparison | |
| Technologicalcharacteristics | N1™ TiUltra™ TCC Implant system | NobelActive WidePlatform (WP) – K133731(Reference #2) | On1 Concept- K161655(Reference #3) | On1 Universal Abutment– K181869 (Reference #6) | Comparison |
| Image: Temporary Abutment Nobel Biocare N1™ Base (Bridge)Image: IOS Healing Abutment Nobel Biocare N1™ Base Tri | Image: On1 IOS Healing Cap: | ||||
| Regulatory Number/Device ClassificationName | 21 CFR§872.3630Endosseous dental implant abutment | 21 CFR§872.3630Endosseous dental implantabutment | 21 CFR§872.3630Endosseous dental implantabutment | 21 CFR§872.3630Endosseous dental implantabutment | Same as Reference #2. |
| Product Code(s) | NHA | NHA | NHA | NHA | Similar, all share theNHA product code. |
| Intended Use | Healing Abutment Nobel BiocareN1™ TCC:Healing Abutments are intended to beused as a temporary component to anendosseous implant to allow healingof the soft tissue.Temporary Abutment Nobel BiocareN1™ TCC:Dental implant abutments are intendedto be used in the upper or lower jawand used for supporting toothreplacements to restore chewingfunction. | Definitive restorationsProvisional restorations | The On1™ devices areintended for use in the fieldof dentistry. They areintended to be used in theupper or lower jaw forsupporting toothreplacements to restorechewing function andesthetics. The On1™ estheticabutments in combinationwith the On1™ Base onNobel Biocare ConicalConnection endosseousimplants are indicated for | The On1™ devices areintended for use in the fieldof dentistry. They areintended to be used in theupper or lower jaw forsupporting toothreplacements to restorechewing function andesthetics. The On1™ estheticabutments in combinationwith the On1™ Base onNobel Biocare ConicalConnection endosseousimplants are indicated for | Same intended use asReference #2, Reference#3, and Reference #6 andexpressed through asimilar choice ofwording. |
| Substantial Equivalence Temporary Abutments | |||||
| Subject Device | Predicate Device | Reference Device | Reference Device | ||
| Technologicalcharacteristics | N1™ TiUltra™ TCC Implant system | NobelActive WidePlatform (WP) – K133731(Reference #2) | On1 Concept- K161655(Reference #3) | On1 Universal Abutment- K181869 (Reference #6) | Comparison |
| Healing Abutment Nobel BiocareN1™ Base Tri:Intended to be temporarily connectedto an endosseous dental implant orimplant abutment to support healingof the surrounding soft tissue.Temporary Abutment Nobel BiocareN1™ Base and Temporary AbutmentNobel Biocare N1™ Base (Bridge):Intended to be connected to anendosseous dental implant to supportthe placement of a dental prosthesis.IOS Healing Abutment Nobel BiocareN1™ Base:Intended to be temporarily connectedto an endosseous dental implant orimplant abutment to support healingof the surrounding soft tissue andtransfer of position of a dental implantor implant abutment to a patientmodel | single-unit cement retainedrestorations. | single-unit cement retainedrestorations. | |||
| Indications for Use | Healing Abutment Nobel BiocareN1™ TCC:Healing abutments are indicated foruse with endosseous dental implantsin the maxilla or mandible forsupporting single tooth to full archdenture procedures. Healingabutments Nobel Biocare N1™ TCCare indicated for use for up to 180days.Temporary Abutment Nobel BiocareN1™ TCC:Are indicated for use with single unitscrew-retained temporary dental | Nobel Biocare'sNobelActive implants areendosseous implantsintended to be surgicallyplaced in the bone of theupper or lower jaw archesto provide support forprosthetic devices, such asan artificial tooth, in orderto restore patient estheticsand chewing function.Nobel Biocare'sNobelActive implants areindicated for single or | The On1TM device is apremanufactured prostheticcomponent directlyconnected to an endosseousimplant and it is intendedfor use in prostheticrehabilitation. | The On1™ device is apremanufactured prostheticcomponent directlyconnected to an endosseousimplant and it is intendedfor use in prostheticrehabilitation.The On1™ UniversalAbutment consists of threemajor parts. Specifically,the On1™ Base, the On1™Universal Abutment, andthe mesostructurecomponents make up a | The Indications for Useare similar to Reference#2, Reference #3, andReference #6 with theonly difference beingchoice of similarwording. |
| Substantial Equivalence Temporary Abutments | |||||
| Technologicalcharacteristics | Subject Device | Predicate Device | Reference Device | Reference Device | Comparison |
| N1TM TiUltraTM TCC Implant system | NobelActive WidePlatform (WP) – K133731(Reference #2) | On1 Concept– K161655(Reference #3) | On1 Universal Abutment– K181869 (Reference #6) | ||
| prostheses placed on endosseousdental implants in the maxilla andmandible, for up to 180 days. | multiple unit restorations insplinted or nonsplintedapplications. NobelBiocare's NobelActiveimplants are intended forimmediate loading whengood primary stability isachieved and withappropriate occlusalloading. | multi-piece abutment. Thesystem integrates multiplecomponents of the digitaldentistry workflow: scanfiles from Intra-OralScanners, CAD software,CAM software, ceramicmaterial, milling machineand associated tooling andaccessories. | |||
| Healing Abutment Nobel BiocareN1TM Base Tri:The Healing Abutment Nobel BiocareN1TM Base is indicated for use with theNobel Biocare N1TM Base XealTM in themaxilla or mandible for supportingsingle unit and multiple unitprocedures, for up to 180 days. | |||||
| Temporary Abutment Nobel BiocareN1TM Base Tri:The Temporary Abutment NobelBiocare N1TM Base is indicated tosupport the placement of single unit,screw-retained temporary prostheticrestorations in the maxilla ormandible, for up to 180 days. | |||||
| Temporary Abutment Nobel BiocareN1TM Base (Bridge):The Temporary Abutment NobelBiocare N1TM Base Bridge is indicatedto support the placement of multipleunit, screw-retained temporaryprosthetic restorations in the maxillaor mandible, for up to 180 days forimplants with less than 20° overalldivergences to allow path of insertion. | |||||
| IOS Healing Abutment Nobel BiocareN1TM Base Tri:The IOS Healing Abutment NobelBiocare N1TM Base is indicated for usewith the Nobel Biocare N1TM BaseXealTM in the maxilla or mandible for |
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| Subject Device | Predicate Device | Reference Device | Reference Device | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Substantial Equivalence Temporary Abutments | |||||||||
| Technologicalcharacteristics | N1™ TiUltra™ TCC Implant system | NobelActive WidePlatform (WP) – K133731(Reference #2) | On1 Concept- K161655(Reference #3) | On1 Universal Abutment– K181869 (Reference #6) | Comparison | ||||
| supporting single unit and multipleunit procedures, for up to 180 days. Incombination with intraoral scanner theIOS Healing Abutment can be used toconfirm the location, position, andorientation of the Nobel Biocare N1™Base Xeal™, to support creation of thedigital model to facilitate the designand fabrication of a dental prosthesisusing CAD/CAM. | |||||||||
| Material | Healing AbutmentNobel Biocare N1™TCCTemporary AbutmentNobel Biocare N1™TCCHealing AbutmentNobel Biocare N1™Base TriTemporary AbutmentNobel Biocare N1™BaseTemporary AbutmentNobel Biocare N1™Base (Bridge)IOS Healing AbutmentNobel Biocare N1™Base Tri | Titanium-aluminum-vanadiumalloy(ASTMF136,ISO5832-3)PEEK | Titanium-aluminum-vanadium alloy(ASTM F136, ISO 5832-3) | Titanium-aluminum-vanadium alloy(ASTM F136, ISO 5832-3) | PEEK | The range of materialsused for the TemporaryAbutments, are thesame as the materialsused for Reference #2,Reference #3, andReference #6. Thedifferences do not raisedifferent questions ofsubstantial equivalenceas demonstrated bybiocompatibility testing. | |||
| Diameter | Healing Abutment NobelBiocare N1™ TCCTemporary AbutmentNobel Biocare N1™ TCC | 4.0 mm,4.5 mm3.4 mm,3.7 mm | HealingAbutment CCWPTemporary SnapAbutment CC | 5.0 mm,6.0 mm,6.5 mm3.4 mm | On1 HealingCapOn1Temporary | 4.775 mm,5.3 mm,6.515 mm3.4 mm,3.7 mm, | 4.775 mm, 5.3 mm | The range of theTemporary Abutment'sdiameters falls withinthat of Reference #2. | |
| Substantial Equivalence Temporary Abutments | |||||||||
| Subject DeviceN1™ TiUltra™ TCC Implant system | Predicate Device | Reference Device | Reference Device | ||||||
| Technologicalcharacteristics | NobelActive WidePlatform (WP) – K133731(Reference #2) | On1 Concept- K161655(Reference #3) | On1 Universal Abutment– K181869 (Reference #6) | Comparison | |||||
| Healing Abutment NobelBiocare N1™ Base Tri | 4.2 mm,4.5 mm | AbutmentEngaging | |||||||
| Temporary AbutmentNobel Biocare N1™ Base | 3.6 mm,3.8 mm | ||||||||
| Temporary AbutmentNobel Biocare N1™ Base(Bridge) | 3.6 mm,3.8 mm | ||||||||
| IOS Healing AbutmentNobel Biocare N1™ BaseTri | 4.2 mm,4.5 mm | ||||||||
| Post Height | Healing Abutment NobelBiocare N1™ TCC | No post | HealingAbutment CCWP | No post | On1 HealingCap | Nopost | No post | The range of theTemporary Abutment'spost height is similar tothat of Reference #2 andReference #3. Thedifferences do not raisedifferent questions ofsubstantial equivalenceas demonstrated byfatigue testing on theconnection. | |
| Temporary AbutmentNobel Biocare N1™ TCC | 10.5 mm | 4.0 mm | On1TemporaryAbutmentEngaging | 8.3, 9.0mm | |||||
| Healing Abutment NobelBiocare N1™ Base Tri | No post | ||||||||
| Temporary AbutmentNobel Biocare N1™ Base | 10.8 mm | ||||||||
| Temporary AbutmentNobel Biocare N1™ Base(Bridge) | 10.5 mm | ||||||||
| IOS Healing AbutmentNobel Biocare N1™ BaseTri | No post | ||||||||
| Gingival Height | Healing Abutment NobelBiocare N1™ TCC | 3.0 mm,5.0 mm,7.0 mm | HealingAbutment CCWP | 3.0 mm,5.0 mm | On1 HealingCap | 1.5 mm,2.5 mm | 4.5 mm, 6.0 mm | The range of theTemporary Abutment'sgingival heights aresimilar to that ofReference #2 andReference #6. Thedifferences do not raisedifferent questions of | |
| Temporary AbutmentNobel Biocare N1™ TCC | 1.5 mm,3.0 mm | TemporarySnap | 1.5 mm,3.0 mm | On1TemporaryAbutmentEngaging | |||||
| Substantial Equivalence Temporary Abutments | Subject Device | Predicate Device | Reference Device | Reference Device | |||||
| Technologicalcharacteristics | N1™ TiUltra™ TCC Implant system | NobelActive WidePlatform (WP) – K133731(Reference #2) | On1 Concept- K161655(Reference #3) | On1 Universal Abutment– K181869 (Reference #6) | Comparison | ||||
| Healing Abutment NobelBiocare N1™ Base Tri | Abutment CCWP | different questions ofsubstantial equivalenceas demonstrated by | |||||||
| Temporary AbutmentNobel Biocare N1™ Base | fatigue testing on theconnection. | ||||||||
| Temporary AbutmentNobel Biocare N1™ Base(Bridge) | |||||||||
| IOS Healing AbutmentNobel Biocare N1™ BaseTri | |||||||||
| Angulation | 0° | 0° | 0° | 0° | Same as Reference #2. | ||||
| Compatible ImplantPlatform | Narrow Platform (NP)Regulator Platform (RP) | Wide Platform (WP) | Narrow Platform (NP)Regulator Platform (RP)Wide Platform (WP) | Narrow Platform (NP)Regulator Platform (RP)Wide Platform (WP) | The same platforms areused in Reference #3.The differences do notraise different questionsof substantialequivalence asdemonstrated by fatiguetesting on theconnection. | ||||
| Connection Interface | HealingAbutment NobelBiocare N1™TCC | Nobel BiocareTri-ovalConicalConnection | HealingAbutmentCC WP | ConicalConnection | On1HealingCap | On1ProstheticConnection | On1 Prosthetic Connection | The connectioninterface has the samefunction as theconnection of Reference | |
| TemporaryAbutment NobelBiocare N1™TCC | Nobel BiocareTri-ovalConicalConnection | TemporaryAbutmentCC WP | HexagonalSnap intoConicalConnection | On1Temporary AbutmentEngaging | On1ProstheticConnection | #2. The differences donot raise differentquestions of substantialequivalence asdemonstrated by fatigue | |||
| HealingAbutment NobelBiocare N1™Base Tri | Nobel BiocareN1 BaseConnection | testing on theconnection. |
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| Substantial Equivalence Temporary Abutments | ||||||
|---|---|---|---|---|---|---|
| Technologicalcharacteristics | Subject Device | Predicate Device | Reference Device | Reference Device | Comparison | |
| N1™ TiUltra™ TCC Implant system | NobelActive WidePlatform (WP) – K133731(Reference #2) | On1 Concept- K161655(Reference #3) | On1 Universal Abutment– K181869 (Reference #6) | |||
| TemporaryAbutment NobelBiocare N1™BaseTemporaryAbutment NobelBiocare N1™Base (Bridge) | ||||||
| IOS HealingAbutment NobelBiocare N1™Base Tri | ||||||
| Surface Treatment | Healing AbutmentNobel Biocare N1™TCC | Anodized | Anodized | None (machined) | The anodized surfacetreatment is the same asReference #2. Themachined surface is thesame as Reference #6.The differences do notraise different questions | |
| Temporary AbutmentNobel Biocare N1™TCC | ||||||
| Healing AbutmentNobel Biocare N1™Base Tri | Anodization | of substantialequivalence asdemonstrated by fatiguetesting on the | ||||
| Temporary AbutmentNobel Biocare N1™Base | connection andbiocompatibility testing. | |||||
| Temporary AbutmentNobel Biocare N1™Base (Bridge) | ||||||
| IOS HealingAbutment NobelBiocare N1™ Base Tri | None(machined) | |||||
| Packaging | Thermoformed polyethyleneterephthalate glycol (PETG) blister | Thermoformedpolyethylene terephthalate | Thermoformedpolyethylene terephthalate | Thermoformedpolyethylene terephthalate | Same as Reference #2. | |
| Substantial Equivalence Temporary Abutments | ||||||
| Subject Device | Predicate Device | Reference Device | Reference Device | |||
| Technologicalcharacteristics | N1™ TiUltra™ TCC Implant system | NobelActive WidePlatform (WP) – K133731(Reference #2) | On1 Concept- K161655(Reference #3) | On1 Universal Abutment– K181869 (Reference #6) | Comparison | |
| tray with medical paper lid forming asterile barrier. | glycol (PETG) blister traywith medical paper lidforming a sterile barrier. | glycol (PETG) blister traywith medical paper lidforming a sterile barrier. | glycol (PETG) blister traywith medical paper lidforming a sterile barrier. | |||
| Sterilization | Gamma sterilization (SAL $10^{-6}$ ) | Gamma sterilization (SAL$10^{-6}$ ) | Gamma sterilization (SAL$10^{-6}$ ) | Steam sterilized by end-user | Same as Reference #2. |
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| Substantial Equivalence for the Screws of the N1 TiUltra TCC Implant system | ||||
|---|---|---|---|---|
| TechnologicalCharacteristics | Subject DeviceN1 TiUltra TCC Implant system | Predicate DeviceOn1 Concept – K161655(Reference #3) | Reference DeviceMulti-unit Abutment Plus – K161416(Reference #7) | Comparison |
| Device Name | Clin Screw Multi-unit Abut Nobel Biocare N1TM TCCProsthetic Screw Nobel Biocare N1TM BaseClinical Screw Nobel Biocare N1TM BaseClinical Screw Nobel Biocare N1TM TCC | On1TM Clinical ScrewOn1TM Prosthetic Screw | Clinical Screws MUA | -- |
| PictorialRepresentation | Clin Screw Multi-unit Abut Nobel Biocare N1 TCCImage: Clin Screw Multi-unit Abut Nobel Biocare N1 TCC | On1 Clinical ScrewImage: On1 Clinical ScrewOn1 Prosthetic ScrewImage: On1 Prosthetic Screw | Clinical Screws MUAImage: Clinical Screws MUA | |
| Clinical Screw Nobel Biocare N1 BaseImage: Clinical Screw Nobel Biocare N1 Base | ||||
| Clinical Screw Nobel Biocare N1 TCCImage: Clinical Screw Nobel Biocare N1 TCC | ||||
| Prosthetic Screw Nobel Biocare N1 BaseImage: Prosthetic Screw Nobel Biocare N1 Base | ||||
| Substantial Equivalence for the Screws of the N1 TiUltra TCC Implant system | ||||
| TechnologicalCharacteristics | Subject DeviceN1 TiUltra TCC Implant system | Predicate DeviceOn1 Concept – K161655(Reference #3) | Reference DeviceMulti-unit Abutment Plus – K161416(Reference #7) | Comparison |
| Regulatory Number /Device ClassificationName | 21 CFR§872.3630Endosseous dental implant abutment | 21 CFR§872.3630Endosseous dental implant abutment | 21 CFR§872.3630Endosseous dental implant abutment | Same as Reference #3. |
| Product Code | NHA | NHA | NHA | Same as Reference #3. |
| Intended Use | Prosthetic Screw Nobel Biocare N1TMBase and Clinical Screw NobelBiocare N1TM Base:The Clinical and Prosthetic Screw areintended to secure a dental abutmentto a dental implant or abutment in theupper or lower jaw and used forsupporting tooth replacements torestore chewing function.Clin Screw Multi-unit Abut NobelBiocare N1TM TCC and Clinical ScrewNobel Biocare N1TM TCC:The Clinical Screw is intended tosecure a dental abutment to a dentalimplant in the upper or lower jaw andused for supporting toothreplacements to restore chewingfunction. | The On1TM devices are intended foruse in the field of dentistry. They areintended to be used in the upper orlower jaw for supporting toothreplacements to restore chewingfunction and esthetics.The On1TM abutments in combinationwith the On1TM Base on NobelBiocare Conical Connectionendosseous implants are indicated forsingle-unit cement and screwretained restorations. | The Clinical Screw, Abutment Screwand Prosthetic Screw are intended tosecure a dental abutment orframework to a dental implant orabutment in the upper or lower jawand used for supporting toothreplacements to restore chewingfunction. | Same intended use asReference #3, expressedthrough similar wording. |
| Indications for Use | Prosthetic Screw Nobel Biocare N1TMBase and Clinical Screw NobelBiocare N1TM Base:The Clinical and Prosthetic Screw areto be directly connected to the dentalimplant, abutment or framework,intended for use as an aid in prostheticrehabilitation.Clin Screw Multi-unit Abut NobelBiocare N1TM TCC and Clinical ScrewNobel Biocare N1TM TCC:Clinical Screws are to be directlyconnected to the dental implant | The On1TM device is apremanufactured prostheticcomponent directly connected to anendosseous implant and it is intendedfor use in prosthetic rehabilitation. | The Multi-unit Abutment Plus is apre-manufactured prostheticcomponent directly connected to theendosseous dental implant and isintended for use as an aid in prostheticrehabilitation. | The Indications for Use aresimilar to Reference #3 withthe only difference being thechoice of similar wording. |
| Substantial Equivalence for the Screws of the N1 TiUltra TCC Implant system | ||||
| TechnologicalCharacteristics | Subject DeviceN1 TiUltra TCC Implant system | Predicate DeviceOn1 Concept - K161655(Reference #3) | Reference DeviceMulti-unit Abutment Plus - K161416(Reference #7) | Comparison |
| abutment or framework, intended foruse as an aid in prostheticrehabilitation. | ||||
| Material | Titanium-aluminum-vanadium alloy(ASTM F136, ISO 5832-3) | Titanium-aluminum-vanadium alloy(ASTM F136, ISO 5832-3) | Titanium-aluminum-vanadium alloy(ASTM F136, ISO 5832-3) | Same as Reference #3. |
| Shaft Diameter | Prosthetic Screw NobelBiocare N1 Base1.25 mm,1.3 mm | On1 Clinical Screw1.185 mm,1.475 mm | 1.17 mm, 1.5 mm | The range of the shaft diametersare similar to those of Reference#3 and Reference #7. Thedifferences do not raise differentquestions of substantialequivalence as demonstrated byfatigue testing. |
| Clin Screw Multi-unitAbut Nobel Biocare N1TCC1.03 mm,1.11 mm | On1 Prosthetic Screw1.175 mm | |||
| Clinical Screw NobelBiocare N1 Base | ||||
| Clinical Screw NobelBiocare N1 TCC | ||||
| Total Length | Prosthetic Screw NobelBiocare N1 Base4.8 mm | On1 Clinical Screw6.870 mm,7.355 mm,7.670 mm,8.105 mm | 7.0 mm | The range of the total length aresimilar to those of Reference #3and Reference #7. Thedifferences do not raise differentquestions of substantialequivalence as demonstrated byfatigue testing. |
| Clin Screw Multi-unitAbut Nobel Biocare N1TCC6.8 mm,6.9 mm,9.7 mm,10.7 mm,11.7 mm,12.7 mm | On1 Prosthetic Screw4.5 mm | |||
| Clinical Screw NobelBiocare N1 BaseClinical Screw NobelBiocare N1 TCC |
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| Substantial Equivalence for the Screws of the N1 TiUltra TCC Implant system | ||||||
|---|---|---|---|---|---|---|
| TechnologicalCharacteristics | Subject DeviceN1 TiUltra TCC Implant system | Predicate DeviceOn1 Concept – K161655(Reference #3) | Reference DeviceMulti-unit Abutment Plus – K161416(Reference #7) | Comparison | ||
| Connection Interface | Prosthetic ScrewNobel Biocare N1Base | Nobel BiocareN1 BaseConnection(N1 Base) | On1 ClinicalScrew | Nobel BiocareInternal ConicalConnection (CC) | Nobel Biocare Internal ConicalConnection (CC) | The connection interface sharesthe same purpose as those inReference #3. The differences donot raise different questions ofsubstantial equivalence asdemonstrated by fatigue testing. |
| Clin Screw Multi-unitAbut Nobel Biocare N1 TCC | Nobel BiocareTri-ovalconicalconnection(TCC) | On1 ProstheticScrew | On1 Base | |||
| Clinical ScrewNobel Biocare N1Base | N1 Base | |||||
| Clinical ScrewNobel Biocare N1TCC | TCC and N1Base | |||||
| Surface treatment | Prosthetic Screw NobelBiocare N1 Base | Anodized,DLCCoating | On1 ClinicalScrew | Anodized, DLCCoating | DLC Coating | Same surface treatments featuredin Reference #3. |
| Clinical Screw NobelBiocare N1 TCC | DLCCoating | On1 ProstheticScrew | DLC Coating | |||
| Clin Screw Multi-unitAbut Nobel BiocareN1 TCC | DLCCoating | |||||
| Clinical Screw NobelBiocare N1 Base | ||||||
| AbutmentCompatibility | Prosthetic ScrewNobel Biocare N1Base | Single unit andMulti-unit | Single unit | Multi-unit | Similar. The abutmentcompatibility is similar betweenReference #3 and Reference #7.The differences do not raisedifferent questions of substantialequivalence as demonstrated byfatigue testing. | |
| Clin Screw Multi-unitAbut Nobel Biocare N1 TCC | Multi-unit | |||||
| Substantial Equivalence for the Screws of the N1 TiUltra TCC Implant system | ||||||
| TechnologicalCharacteristics | Subject DeviceN1 TiUltra TCC Implant system | Predicate DeviceOn1 Concept – K161655(Reference #3) | Reference DeviceMulti-unit Abutment Plus - K161416(Reference #7) | Comparison | ||
| Clinical ScrewNobel Biocare N1Base | Single unit andMulti-unit | |||||
| Clinical ScrewNobel Biocare N1TCC | Single unit | |||||
| Anatomical Site | Narrow Platform (NP)Regular Platform (RP) | Narrow Platform (NP)Regular Platform (RP)Wide Platform (WP) | Narrow Platform (NP)Regular Platform (RP)Wide Platform (WP) | Same, within the subset ofReference #3. | ||
| Packaging | Thermoformed polyethyleneterephthalate glycol (PETG) blister traywith medical paper lid forming a sterilebarrier. | Thermoformed polyethyleneterephthalate glycol (PETG) blister traywith medical paper lid forming a sterilebarrier. | Thermoformed polyethyleneterephthalate glycol (PETG) blister traywith medical paper lid forming a sterilebarrier. | Same as Reference #3. | ||
| Sterilization | Gamma sterilization (SAL 10-6) | Gamma sterilization (SAL 10-6) | Gamma sterilization (SAL 10-6) | Same as Reference #3. |
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Summary of Non-Clinical Testing
The following performance tests were submitted in this 510(k) to support substantial equivalence:
- Sterilization validation was conducted in accordance with: ●
- ISO 11137-1:2006, Sterilization of health care products -- Radiation -- Part 1 : o Requirements for development, validation and routine control of a sterilization process for medical devices;
- ISO 11137-2:2013, Sterilization of health care products -- Radiation -- Part 2: о Establishing the sterilization dose;
- ISO 11737-1:2018, Sterilization of health care products Microbiological o methods - Part 1: Determination of a population of microorganisms on products; and
- ISO 11737-2:2009, Sterilization of medical devices Microbiological methods о - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
- Endotoxin testing was conducted in accordance with: ●
- USP 43-NF38:2020, <161> Medical Devices-Bacterial Endotoxin and Pyrogen о Tests:
- USP 43-NF38:2020, <85> Bacterial Endotoxins Test; and o
- ANSI/AAMI ST72:2011/(R)2016. Bacterial endotoxins Test methods, routine O monitoring, and alternatives to batch testing.
- End user cleaning and sterilization validation was conducted in accordance with: ●
- ISO 17665- 1:2006, Sterilization of health care products Moist heat Part 1: o Requirements for the development, validation and routine control of a sterilization process for medical devices;
- AAMI TIR12:2010. Designing, testing and labeling reusable medical devices for о reprocessing in health care facilities: A guide for device manufacturers;
- 0 AAMI / ANSI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities;
- ANSI/AAMI ST77:2013. Containment devices for reusable medical device O sterilization; and
- ISO 17664:2017, Processing of health care products Information to be provided o by the medical device manufacturer for the processing of medical devices.
- Packaging performance testing was conducted in accordance with: ●
- ISO 11607-1:2019, Packaging for terminally sterilized medical devices Part 1: o Requirements for materials, sterile barrier systems and packaging systems;
- ASTM D4169:2016, Standard Practice for Performance Testing of Shipping о Containers and Systems;
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- ASTM D4332: 2014, Standard Practice for Conditioning Containers, Packages, o or Packaging Components for Testing;
- ASTM F1886 / F1886M:2016, Standard Test Method for Determining Integrity of O Seals for Flexible Packaging by Visual Inspection;
- ASTM F2096: 2011. Standard Test Method for Detecting Gross Leaks in O Packaging by Internal Pressurization (Bubble Test); and
- ASTM F1980:2016, Standard Guide for Accelerated Aging of Sterile Barrier O Systems for Medical Devices.
- Biocompatibility testing was conducted in accordance with: ●
- ISO 10993-1:2018, Biological evaluation of medical devices Part 1: O Evaluation and testing within a risk management process;
- O ISO 10993-5:2009, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity;
- ISO 10993-12:2012, Biological evaluation of medical devices Part 12: Sample O preparation and reference materials; and
- ISO 10993-18:2020, Biological evaluation of medical devices Part 18: O Chemical characterization of medical device materials within a risk management process.
- Mechanical testing was conducted according to ISO 14801:2016, Dentistry -- Implants ● — Dynamic loading test for endosseous dental implants and the FDA Guidance Document entitled, "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004).
- Heat generation testing and insertion torque testing was conducted with the N1 TiUltra TCC Implant system and the Primary Predicate. The comparative testing demonstrated the equivalence of the subject device to the predicate device.
- An Animal Study was conducted with the N1 TiUltra TCC Implant system and TiUltra ● Implants and Xeal Abutments (K202344) in a mini-pig model to evaluate the performance of the new drilling technique. The comparative study provided supportive data through: clinical observations, x-ray evaluation, micro-CT, and histology and histomorphometry to assess osseointegration at 13 ± 2 weeks. The devices exhibited the same representative osseointegration behavior at the assessed timepoint.
- Mesostructure verification and validation was completed on the Universal Abutments Nobel Biocare N1™ with the softwares and designated workflows. Software verification was provided for the subject abutment design library to demonstrate use with the softwares. Software verification demonstrated that the restrictions prevent design of the mesostructure component outside of design limitations. In addition, the abutment design library was validated to demonstrate that the established design limitations and specifications are locked and cannot be modified within the abutment design library.
- MR conditional labeling was leveraged from Nobel Biocare Dental Implant Systems . Portfolio - MR Conditional - K212125 (Reference #8). The same type of testing was
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conducted for the Subject Device and had acceptable outcomes to validate the labeling for MR Conditional.
The results of the non-clinical testing demonstrated that the N1 TiUltra TCC Implant system met the established performance specifications per intended use. The non-clinical testing also demonstrated that the N1 TiUltra TCC Implant system does not raise different questions of substantial equivalence when compared to the respective predicate devices.
Summary of Clinical Testing
To evaluate the long-term performance, osseointegration, and local effects of implantation that were unable to be fully addressed by the animal study, multiple sources of real-world evidence were provided to address concerns regarding the novel implant site preparation protocol (ISP) which employs fewer instruments and, in some steps, uses lower drill speeds and no irrigation in comparison to the ISP of the K142260 Primary Predicate, NobelActive. This body of clinical data addressed the necessary evaluation of critical clinical parameters for at least 12-months post-loading, including soft and hard tissues and bone loss, to support the success and safety of the Subject Device and its associated ISP drilling technique. These sources included a retrospective, multi-center, company-sponsored real-world study, supportive published literature, justification and detailed gap analysis of the representative test article, post-market surveillance data, clinical case studies, and clinical data gap analysis.
The primary clinical evidence was provided by the Nobel Biocare T-193 Evolution Study, a retrospective, multi-center, company-sponsored real-world study ("T-193 EVOLUTION Study"), conducted in Europe using a representative article, the Nobel Biocare N1 Concept System. The data provided in this study aligned with the recommendations of the FDA Guidance Document "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices." The study reported on 95 consecutive subjects, treated with 165 implants, out of which 145 implants had 12-month follow-up visit data after loading at study end, and included clinical and radiographic imaging data from the timepoint of surgery up to 12-months after loading. The primary endpoint was marginal bone level change (MBLC) of the Nobel Biocare N1 Concept System between the timepoint of implant loading to 12-months post loading. Secondary endpoints included implant survival and success rates at 12-months after loading, soft tissue healing parameters (i.e., bleeding index, plaque index, etc.) at 12-months after loading, and safety as recorded by adverse events (Device Deficiency, Adverse Device Effect, Serious Adverse Device Effect, and Unanticipated Serious Adverse Device Effect). Marginal bone level change (MBLC) from baseline (loading) to the 12-month follow-up visit, showed increased bone of 0.15 ± 0.84 mm (n=124 implants - for paired image analysis). Non-inferiority of marginal bone level change for Nobel Biocare N1 Concept System compared to historic data for NobelActive implant system (MacLean et al., 2016, and Aldahlawi,et al., 2018).11-21 The primary endpoint of non-inferiority to published MBLC data of the Subject Device's Primary Predicate, NobelActive (K142260), was met with a statistical significance of p<0.001. The secondary endpoints for implant survival, implant success, tissue health, and safety events also resulted in clinically favorable outcomes. The successful clinical assessments and long-term results of clinical data evaluated also supported the biocompatibility of the Subject Devices related to the potential challenges associated with the novel ISP on local effects of implantation.
To address concerns relative to the use of a representative iteration of the Subject Device in the T-193 EVOLUTION Study, an assessment of the Subject Device's design and discussion of how the
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Nobel Biocare N1 Concept System is representative of the Subject Device was provided. The design change assessment included details of the changes in design parameters (e.g., implant macro geometries), the reason for the change, and how the change may have impacted clinical performance demonstrated in the T-193 EVOLUTION Study's results. The impact of the changes on clinical performance was assessed by identifying biomechanical aspects of dental system designs which attribute to long-term performance, assessing each of these aspects thoroughly, and conducting a finite element analysis to assess implant loading distribution. Based on the individual and sum of the design changes, (i.e., including changes to the implant site preparation tools and protocol, the prosthetics, and the implants) as well as the use of a finite element analysis to model implant load distribution, the assessment concluded that the representative article (Nobel Biocare N1 Concept System) is the worst-case system and representative of the Subject Device.
Additional sources of real-world evidence provided to support the substantial equivalence of the Subject Device included the following:
- . Post-Market Surveillance (PMS) data collected for the Subject Device as well as the associated restorative components from CE-mark accepting countries from May 2020 up to July 2021. Complaint rates associated with Nobel Biocare N1™ TiUltra™ TCC implants (Subject Device) were compared to the complaint rates of Primary Predicate NobelActive (K142260) during its first year of marketing (2008-2009) and were found to be lower.
- Supportive Published Literature was provided to add context to the T-193 EVOLUTION Study design and includes a discussion of how each publication was leveraged for the design of the T-193 EVOLUTION Study, including study endpoints, related indices, sample size calculation, calculation of marginal bone level change and implant survival rate. Several of the studies published historical data for NobelActive, the Subject Device's Primary Predicate (K142260).
- . Clinical Data Gap Analysis - As all the clinical data presented is considered Real World Evidence, a gap analysis for each type of data was provided to demonstrate how the characteristics and evaluations of the real-world clinical evidence is relevant and reliable in order to demonstrate substantial equivalence of the Subject Device per the proposed intended use.
In summary, the totality of real-world evidence provided: the retrospective. multicenter clinical study, the post-market surveillance (PMS) data collected, supportive literature review provided to support the clinical study protocols and design, including studies published on the K142260 Primary Predicate, and the clinical data gap analysis was used to support the substantial equivalence of the Subject Device system, the N1 TiUltra TCC Implant System, to its Primary Predicate and identified reference devices.
[1] MacLean S, Hermans M, Villata L, et al. A retrospective multicenter case series evaluating a novel 3.0-mm expanding tapered body implant for the rehabilitation of missing incisors. Quintessence Int 2016;47(4):297-306
[2] Aldahlawi S, Demeter A, Irinakis T. The effect of implant placement torque on crestal bone remodeling after 1 year of loading. Clin Cosmet Investig Dent. 2018;10:203-9.
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Conclusions
The N1 TiUltra TCC Implant system was evaluated for substantial equivalence using standard and/or comparative testing. Based on a comparison of intended use, Indications for Use, material composition, technological characteristics, features, and performance (non-clinical and clinical) data the N1 TiUltra TCC Implant system is substantially equivalent to the predicate device.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.