(251 days)
NobelActive K142260
No
The summary describes a dental implant system and its components, with no mention of AI or ML in the device description, intended use, or performance studies. The studies focus on clinical outcomes and mechanical properties of the physical implant.
Yes
The device is used to restore patient esthetics and chewing function, which can be considered a therapeutic function.
No
The device is an implant system designed to restore patient esthetics and chewing function, not to diagnose a condition.
No
The device description explicitly states it is composed of implant site preparation tools, abutments, and abutment screws, which are physical hardware components. The performance studies also detail testing on physical aspects like mechanical properties, sterilization, and an animal study.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function." This describes a surgical implant and its components, not a test performed on samples taken from the body.
- Device Description: The device is described as being composed of "implant site preparation tools, abutments, and abutment screws." These are physical components used in a surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. The performance studies focus on clinical outcomes related to the implant's function and bone integration, not diagnostic accuracy.
Therefore, the N1™ TiUltra™ TCC Implant system is a medical device used for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
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 healing 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.
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.
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, screw-retained 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA, PNP, QRQ
Device Description
N1 TiUltra TCC Implant system is composed of implant site preparation tools, abutments, and abutment screws. The Device Lines that when used together form the N1 TiUltra TCC Implant system are: Nobel Biocare N1™ TiUltra™ TCC implants (Endosseous dental implant), OsseoShaper (Instruments for bone preparation), Multi-unit Abutment Xeal™ Nobel Biocare N1™ TCC (Endosseous dental abutment), Universal Abutments Nobel Biocare N1™ (Endosseous dental abutment), Temporary Abutments (Endosseous dental abutment), and Screws (Screws for endosseous dental abutments).
Nobel Biocare N1™ TiUltra™ TCC implants (Item 1): Consists of a dental implant (i.e., Nobel Biocare N1™ 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. Includes the Cover Screw Nobel Biocare N1™ TCC.
OsseoShaper (Item 2): Rotating implant site preparation tools to be used at low speed (50rpm) without irrigation. OsseoShaper 1 Nobel Biocare N1™ is used to reach desired depth and position. OsseoShaper 2 Nobel Biocare N1™ is used when OsseoShaper 1 does not reach desired depth.
Multi-unit Abutment Xeal™ Nobel Biocare N1™ TCC (Item 3): Transmucosal abutments used for multiple unit screw retained restorations. Available in Narrow Platform (NP) and Regular Platform (RP), feature a tri-oval conical connection (TCC), and compatible with Nobel Biocare N1 TiUltra TCC implants.
Universal Abutments Nobel Biocare N1™ (Item 4): Consists of Universal Abutment Nobel Biocare N1™ TCC, Universal Abutment Nobel Biocare N1™ Base Tri, Universal Abutment Nobel Biocare N1™ Base Tri (Bridge), and Nobel Biocare N1™ Base Xeal™ TCC Tri. These are pre-manufactured dental implant abutments connectable directly to Nobel Biocare N1 TiUltra TCC implant or Nobel Biocare N1 Base Xeal TCC Tri to support screw-retained dental prosthesis. The system integrates digital dentistry workflow components like Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
Temporary Abutments (Item 5): Consists of 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), and IOS Healing Abutment Nobel Biocare N1™ Base Tri. These are pre-manufactured dental implant abutments for healing support or temporary prosthesis placement.
Screws (Item 6): Includes Clin Screw Multi-unit Abut Nobel Biocare N1™ TCC, Prosthetic Screw Nobel Biocare N1™ Base, Clinical Screw Nobel Biocare N1™ Base, and Clinical Screw Nobel Biocare N1™ TCC. These are pre-manufactured dental implant screws designed to fix dental prostheses or components to dental implants or abutments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Testing:
Performance tests were conducted to support substantial equivalence, including:
- Sterilization validation: In accordance with ISO 11137-1:2006, ISO 11137-2:2013, ISO 11737-1:2018, and ISO 11737-2:2009.
- Endotoxin testing: In accordance with USP 43-NF38:2020 ( and ), and ANSI/AAMI ST72:2011/(R)2016.
- End user cleaning and sterilization validation: In accordance with ISO 17665-1:2006, AAMI TIR12:2010, AAMI / ANSI ST79:2017, ANSI/AAMI ST77:2013, and ISO 17664:2017.
- Packaging performance testing: In accordance with ISO 11607-1:2019, ASTM D4169:2016, ASTM D4332:2014, ASTM F1886 / F1886M:2016, ASTM F2096:2011, and ASTM F1980:2016.
- Biocompatibility testing: In accordance with ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-12:2012, and ISO 10993-18:2020.
- Mechanical testing: According to ISO 14801:2016 and FDA Guidance Document "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: Comparative testing with the N1 TiUltra TCC Implant system and the Primary Predicate demonstrated equivalence.
- Animal Study: (Mini-pig model) Conducted with the N1 TiUltra TCC Implant system and TiUltra Implants and Xeal Abutments (K202344) to evaluate the performance of the new drilling technique. Clinical observations, x-ray, micro-CT, and histology/histomorphometry at 13 ± 2 weeks showed similar osseointegration behavior.
- Mesostructure verification and validation: Completed on Universal Abutments Nobel Biocare N1™ with relevant softwares and workflows. Software verification demonstrated design library use and software restrictions, and validation confirmed locked design limitations.
- MR conditional labeling: Leveraged from Nobel Biocare Dental Implant Systems Portfolio - MR Conditional - K212125 (Reference #8). Acceptable outcomes validated MR Conditional labeling.
Results of non-clinical testing demonstrated that the N1 TiUltra TCC Implant system met established performance specifications and did not raise different questions of substantial equivalence.
Summary of Clinical Testing:
To evaluate long-term performance, osseointegration, and local effects of implantation, real-world evidence was provided, addressing concerns regarding the novel implant site preparation protocol (ISP) which uses fewer instruments, lower drill speeds, and no irrigation compared to the predicate's ISP. This included:
- Retrospective, multi-center, company-sponsored real-world study: "Nobel Biocare T-193 Evolution Study" ("T-193 EVOLUTION Study"), conducted in Europe using the Nobel Biocare N1 Concept System.
- Sample size: 95 consecutive subjects, 165 implants. 145 implants had 12-month follow-up data after loading.
- Endpoints:
- Primary: Marginal bone level change (MBLC) of the Nobel Biocare N1 Concept System between implant loading and 12-months post loading.
- Secondary: Implant survival and success rates, soft tissue healing parameters (bleeding index, plaque index), and safety (adverse events).
- Results:
- MBLC: Increased bone of 0.15 ± 0.84 mm (n=124 implants for paired image analysis).
- Non-inferiority: Non-inferiority of MBLC compared to historical data for NobelActive implant system (MacLean et al., 2016, and Aldahlawi, et al., 2018) was met with statistical significance (p
§ 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.
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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.
1
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
2
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 SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration 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 or
supporting prosthetic teeth, in order to restore patient esthetics and chewing function. N1TM
TiUltraTM 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 N1TM and OsseoShaper 2 Nobel Biocare N1TM | |
| The N1TM 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 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 implant
platform 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 the
endosseous 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 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. | |
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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 Systems | ||
| Portfolio - 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 Implant | |||
| system | 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 Nobel | ||
| Biocare N1™ | Endosseous dental abutment | ||
| 5 | Temporary Abutments | Endosseous dental abutment | |
| 6 | Screws | Screws for endosseous dental | |
| abutments |
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 Medical Devices-Bacterial Endotoxin and Pyrogen о Tests:
- USP 43-NF38:2020, 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