(204 days)
· NobelProcera® Zirconia Abutment/Implant Crown N1™ Base:
The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base is a patient-matched CAD/CAM prosthetic component directly connected to an endosseous dental implant abutment with the Prosthetic Screw and is indicated for use as an aid in prosthetic rehabilitation.
· Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base:
The Prosthetic Screw is to be directly connected to the dental abutment or crown, indicated for use as an aid in prosthetic rehabilitation.
NobelProcera® Zirconia N1™ Base (premanufactured and patient matched prosthetic components) is composed of two subject device lines:
- NobelProcera® Zirconia Abutment / Implant Crown N1™ Base and -
- -Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base
The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is a patient-matched specific CAD/CAM dental prosthesis which is connected to dental implants via a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri) and is intended for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance. The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is available as device in two restorative design solutions as described following:
a) The Abutment design is intended to mimic a prepared tooth which is then finalized with a restoration
b) The Implant Crown design incorporates part or all of the final restoration (i.e. Crown) into its design
The abutment / implant crowns are manufactured from zirconia (Yttria stabilized tetragonal zirconia according to ISO 13356) and are designed in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using dental CAD/CAM software and a Nobel Biocare/KaVo approved dental scanner. The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base can be modeled with conventional impression, using a model to be scanned with a desktop scanner or directly with an intra oral scan with a Nobel Biocare/Kavo approved scanner. The finished design is sent to Nobel Biocare manufacturing facility for industrial production. After production, the abutment / implant crown is sent to the laboratory for finishing.
NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is provided with the required Prosthetic Screw, the Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base which is a pre-manufactured dental prosthetic screw used to fasten the NobelProcera® Zirconia Abutment / Implant Crown N1™ Base to a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri). The Prosthetic Screw NobelProcera® Zr Nobel Biocare N1 ™ Base is made of titanium alloy according to ASTM F136 / ISO 5832-3.
The subject device lines are components of a two-piece abutment construct which consists of the Nobel Biocare N1™ Base Xeal™ TCC Tri (K211109) screw-retained using the Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base (subject device line) to the NobelProcera® Zirconia Abutment / Implant Crown N1™ (subject device line).
The provided document is a 510(k) premarket notification for a dental device, specifically the NobelProcera® Zirconia N1™ Base and its associated Prosthetic Screw. The notification aims to demonstrate substantial equivalence to previously marketed predicate devices, rather than establishing de novo acceptance criteria or proving performance against novel criteria through clinical studies. Therefore, much of the requested information regarding a device meeting specific acceptance criteria and the nature of the study that proves it, as it would apply to a new classification or a device with new indications requiring extensive clinical validation, is not directly available or applicable in the provided context of a 510(k) submission for substantial equivalence.
However, I can extract information related to the performance data used to support substantial equivalence, which serves a similar purpose to demonstrating acceptance criteria in this regulatory pathway. The acceptance criteria here are implicitly alignment with the performance of the predicate and reference devices.
Here's a summary based on the provided text, addressing what can be inferred or directly stated:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present explicit "acceptance criteria" in a quantitative table format that a device must meet to be considered "safe and effective." Instead, it focuses on demonstrating substantial equivalence by comparing its characteristics and performance to legally marketed predicate and reference devices. The "reported device performance" is primarily comparative in nature.
Implicit Acceptance Criteria (Demonstrated Equivalence) & Reported Performance:
| Category | Implicit Acceptance Criteria (Comparative) | Reported Device Performance (Summary from Submission) |
|---|---|---|
| Indications for Use | Same as predicate/reference devices. | NobelProcera® Zirconia Abutment / Implant Crown N1™ Base: Same as Primary Predicate (On1 Concept - K161655), expressed through similar wording. Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base: Same as Reference Device No. 1 (Prosthetic Screw Nobel Biocare N1™ Base), expressed through similar wording. |
| Technological Characteristics | Similar to predicate/reference devices, with any differences not raising new concerns. | NobelProcera® Zirconia Abutment / Implant Crown N1™ Base: Device design, compatible Implant/Base platforms (NP/RP), device connection/connector, materials of the connector, screw access, and device attachment method are identical or similar to the Primary Predicate. Ceramic material is Y-TZP, similar to predicate, and specifically "Nacera Pearl" (K143071), which is also used in Reference Device No. 1. Design methods, ASC angulation (0°-25°), and dimensions are similar to Reference Device No. 2. Maximum device body angulation limits are similar to Reference Device No.1, with differences substantiated by fatigue testing. Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base: Principle of operation, compatible Implant/Base platforms (NP/RP), device material (Ti6Al4V ELI), thread design, and screw interfaces (Omnigrip Mini) are the same as Reference Device No. 1. DLC coating applied to screw body, similar to Reference Device No. 1. Differences in screw body dimensions, anodization (subject device is not anodized), and packaging do not raise new concerns. |
| Performance (Non-clinical) | Performance as good as predicate/reference devices for intended use, as demonstrated by recognized standards (e.g., ISO 14801, ISO 10993-1, ASTM). | Fatigue Performance: Dynamic loading testing performed according to ISO 14801. Testing found acceptable, including evaluation of removal torque and no screw-loosening for run-out samples. Biocompatibility: Demonstrated according to ISO 10993-1. Wear Assessment: Light optical and SEM imaging following ISO 14801 fatigue loading showed similar wear patterns to reference device systems (NobelProcera® Zirconia Implant Bridge (K202452) and NobelProcera® ASC Abutment CC (K132746)). Packaging System Performance: Tested per ASTM D4169. Magnetic Resonance Compatibility: Tested according to ASTM F2052, ASTM F2213, ASTM F2119, and ASTM F2182. Cleaning and Sterilization Validation: End user cleaning and sterilization validation in accordance with ISO 17665-1 and AAMI TIR12. |
| Performance (Clinical/Real-World Evidence) | No evidence of new safety/effectiveness concerns with differences in materials or design. | Post-Market Surveillance (PMS) Data: - NPr ASC Ab Zirconia CC (K132746): 8.1 years in patient, low complaint rates, no concerns regarding dissimilar materials (DLC-coated screw with Zirconia abutment). - NobelProcera® Zr Implant Bridge (K202452): 1.7 years in patient, low complaint rates, no concerns regarding dissimilar materials. Clinical Data: Five clinical studies on NPr ASC Ab Zirconia CC (K132746) with mean follow-ups of 0.6-3.6 years, reporting on 277 devices. No reports of wear debris from Zirconia/DLC-coated screw contact or other adverse events raising concerns about dissimilar materials. A gap analysis was provided to support the relevance and reliability of this real-world evidence. |
2. Sample Size for the Test Set and Data Provenance
The document does not define a single "test set" in the context of a clinical trial for direct performance measurement. Instead, it refers to various non-clinical tests and real-world evidence.
- Non-clinical testing (Fatigue, Wear, MRI Compatibility, Packaging): The sample sizes for these specific tests are not provided in the summary. For example, ISO 14801 fatigue testing typically involves a certain number of samples (e.g., n=10-12 per group) but this detail is omitted.
- Real-World Evidence (PMS Data):
- NPr ASC Ab Zirconia CC (K132746): Data collected from December 2013 up to January 2022. The longest time in a patient was approx. 8.1 years.
- NobelProcera® Zr Implant Bridge (K202452): Data collected from May 2020 up to January 2022. The longest time in a patient was approx. 1.7 years.
- Data Provenance: This is post-market surveillance data, likely originating from clinical use of the cleared predicate/reference devices, implicitly from various countries where Nobel Biocare products are marketed. It is retrospective in nature.
- Clinical Data (NPr ASC Ab Zirconia CC):
- Sample Size: 277 NPr ASC Ab Zirconia CC (K132746) devices were reported across 5 clinical studies.
- Data Provenance: The document states the studies were "included consecutively with no selection regarding study inclusion made besides the inclusion criterion that the NPr ASC Ab Zirconia CC had to be used in the study." The studies were published in international journals, suggesting prospective clinical studies from potentially diverse geographical origins, but specific countries are not mentioned (e.g., "[1] Greer, A.C., et al., Int J Prosthodont, 2017"). These are considered Real World Evidence in this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This specific information is not provided in the document. For 510(k) submissions focusing on substantial equivalence, the "ground truth" for the test set is usually the performance of the predicate device as established by its clearance and recognized standards, rather than a new expert consensus process for the subject device. The clinical studies mentioned were about observing device performance in patients, not establishing a new ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typical for interpreting subjective endpoints in clinical trials or for establishing ground truth from multiple expert readings (e.g., in AI/imaging studies). The provided clinical evidence references published studies with their own methodologies, which are not detailed here.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The studies cited are focused on the clinical performance and safety of existing devices (predicates/references) and a "gap analysis" for using that as real-world evidence for the subject device, or non-clinical engineering tests. There is no mention of comparing human readers with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical dental abutment and prosthetic screw, not an AI algorithm or software. Therefore, there is no "standalone" performance in the context of an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence is primarily:
- Engineering Standards: Compliance with ISO 14801, ISO 10993-1, ASTM F2052, F2213, F2119, F2182, ISO 17665-1, AAMI TIR12.
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate and reference devices (On1 Concept K161655, N1™ TiUltra™ TCC Implant system K211109, NobelProcera Angulated Screw Channel Abutment Conical Connection K132746, Nacera Pearl K143071).
- Outcomes Data/Real-World Evidence: Post-market surveillance data and clinical study outcomes for the predicate/reference devices, showing low complaint rates, good tissue health, and no unexpected adverse events related to material interactions. These outcomes serve as a proxy for acceptable performance.
8. The Sample Size for the Training Set
This concept is not applicable as the device is a physical dental component and not an AI/machine learning model that undergoes a "training" phase with a dataset.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reason as point 8.
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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 Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Nobel Biocare Services AG Bernice Jim Head of RA Product Development and Marketed Products Balz Zimmermann-Str. 7 Kloten, Zurich 8302 SWITZERLAND
Re: K220048
Trade/Device Name: NobelProcera® Zirconia N1TM Base Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 29, 2022 Received: June 30, 2022
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 mediation-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) K220048
Device Name NobelProcera® Zirconia N1TM Base
Indications for Use (Describe)
· NobelProcera® Zirconia Abutment/Implant Crown N1™ Base:
The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base is a patient-matched CAD/CAM prosthetic component directly connected to an endosseous dental implant abutment with the Prosthetic Screw and is indicated for use as an aid in prosthetic rehabilitation.
· Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base:
The Prosthetic Screw is to be directly connected to the dental abutment or crown, indicated for use as an aid in prosthetic rehabilitation.
| 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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Image /page/3/Picture/0 description: The image contains the logo for Nobel Biocare. The logo consists of a red square with a stylized white "N" inside it. To the right of the square is the text "Nobel Biocare" in black font. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".
510(k) Summary — K220048
NobelProcera® Zirconia N1™ Base
- Submitter Information
Submitter:
Nobel Biocare AB Vastra Hamngatan 1 Goteborg 411 17 Sweden
Submitted By:
Nobel Biocare Services AG Balz-Zimmerman-Strasse 7 8302 Kloten Switzerland
Contact Person: E-Mail: Prepared By: Date Prepared
Bernice Jim, Ph.D. regulatory.affairs@nobelbiocare.com Manfred Müller 29 July 2022
- Device Name
| Proprietary name: | NobelProcera® Zirconia N1™ Base |
|---|---|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA |
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3. Predicate Device
| Primary Predicate | |
|---|---|
| Propriety Name: | On1 Concept (K161655) |
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | Class II |
| Product Code: | NHA |
Reference Device No. 1
| Proprietary Name: | N1™ TiUltra™ TCC Implant system (N1™ system; K211109) |
|---|---|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Implants |
| Classification Name: | Endosseous Dental Implant |
| Regulation Number: | 21 CFR§872.3640 |
| Regulatory Class: | II |
| Product Code: | DZE, NHA, PNP, QRQ |
Reference Device No. 2
| Propriety Name: | NobelProcera Angulated Screw Channel Abutment ConicalConnection (K132746) |
|---|---|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | Class II |
| Product Code: | NHA |
4. Device Description
NobelProcera® Zirconia N1™ Base (premanufactured and patient matched prosthetic components) is composed of two subject device lines:
- NobelProcera® Zirconia Abutment / Implant Crown N1™ Base and -
- -Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base
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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 NobelProcera® Zirconia N1™ Base (premanufactured and patient matched prosthetic components) because the submission covers several devices used together for a dental prosthetic procedure which has similar supportive data, and one FDA review division will be involved.
The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is a patient-matched specific CAD/CAM dental prosthesis which is connected to dental implants via a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri) and is intended for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance. The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is available as device in two restorative design solutions as described following:
a) The Abutment design is intended to mimic a prepared tooth which is then finalized with a restoration
b) The Implant Crown design incorporates part or all of the final restoration (i.e. Crown) into its design
The abutment / implant crowns are manufactured from zirconia (Yttria stabilized tetragonal zirconia according to ISO 13356) and are designed in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using dental CAD/CAM software and a Nobel Biocare/KaVo approved dental scanner. The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base can be modeled with conventional impression, using a model to be scanned with a desktop scanner or directly with an intra oral scan with a Nobel Biocare/Kavo approved scanner. The finished design is sent to Nobel Biocare manufacturing facility for industrial production. After production, the abutment / implant crown is sent to the laboratory for finishing.
NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is provided with the required Prosthetic Screw, the Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base which is a pre-manufactured dental prosthetic screw used to fasten the NobelProcera® Zirconia Abutment / Implant Crown N1™ Base to a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri). The Prosthetic Screw NobelProcera® Zr Nobel Biocare N1 ™ Base is made of titanium alloy according to ASTM F136 / ISO 5832-3.
The subject device lines are components of a two-piece abutment construct which consists of the Nobel Biocare N1™ Base Xeal™ TCC Tri (K211109) screw-retained using the Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base (subject device line) to the NobelProcera® Zirconia Abutment / Implant Crown N1™ (subject device line).
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Principle of Operation / Mechanism of Action
The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base are used for dental restoration purposes. The Zirconia abutments / implant crowns are mechanically connected to an endosseous implant via a titanium base adapter (Nobel Biocare N1™ Base Xeal™ TCC Tri) with the Subject Device line Prosthetic Screw NobelProcera® Zr Nobel Biocare N1 ™ Base to restore chewing function.
Patient Contacting Components
Following the assessment set forth in ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, Annex A, it was determined that the NobelProcera® Zirconia N1™ Base (premanufactured and patient matched prosthetic components) device lines do contain patient contacting materials. The device component's categorization and contact duration and identification of material or color additive are listed in Table 1.
| Subject device lines | Device Category &Contact Duration | Material & Surface TreatmentDescription | Identification of ColorAdditive |
|---|---|---|---|
| NobelProcera® ZirconiaAbutment / Implant Crown N1 ™Base | Permanent Implant Device(>30 days) | Nacera Pearl: Yttria-stabilizedtetragonal zirconia (Y-TZP)(according to ISO 13356) | No Color Additive |
| Prosthetic ScrewNobelProcera® Zr NobelBiocare N1™ Base | Permanent Implant Device(>30 days) | Titanium vanadium alloy:90% Ti, 6% Al, 4% V(according to ASTM F136 / ISO5832-3)Diamond Like Carbon coating(DLC) | No Color Additive |
Table 1: Patient Contacting Material List for NobelProcera® Zirconia N1™ Base (premanufactured and patient matched prosthetic components) device lines
Compatible Devices and accessories:
The NobelProcera® Zirconia Abutment / Implant Crown N1™ Base is intended to be used with the following previously cleared or exempt accessories/devices from Nobel Biocare in Table 2 below. The subject device line Prosthetic Screw NobelProcera® Zr Nobel Biocare N1 ™ Base is included in the table as well for the purpose of comprehensiveness.
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Table 2: NobelProcera® Zr Nobel Biocare N1™ Base Device/Accessory compatibility overview
| Device /Accessory | Nobel BiocareN1TM Base XealTMTCC Tri(Article number) | Screw DriverMachineOmnigripTM Mini(Article number) | Screw DriverManualOmnigripTM Mini(Article number) | Prosthetic screwNobel Procera® ZrNobel BiocareN1TM Base(Article number) | Lab ScrewNobelProcera® ZrNobel BiocareN1TMBase(Article number) | Base ReplicaNobel BiocareN1TM Base Tri(Article number) | IOS Base ReplicaNobel BiocareN1TM Base Tri(Article number) |
|---|---|---|---|---|---|---|---|
| PictorialRepresentation | |||||||
| Article Numbers(Platform: NP) | 300982, 300983;300984 | 300852; 300853;300854; | 300855; 300856 | 301031 | 301035 | 301021 | 301024 |
| Article Numbers(Platform: RP) | 300985, 300986;300987 | 301032 | 301036 | 301022 | 301025 | ||
| Manufacturer | Nobel Biocare | Nobel Biocare | Nobel Biocare | Nobel Biocare | Nobel Biocare | Nobel Biocare | Nobel Biocare |
| Classification | Class II | Class I | Class I | Class II | Class II | Class I | Class I |
| RegulationNumber | 872.3630 | 872.3980 | 872.3980 | 872.3630 | 872.3980 | 872.3980 | 872.3980 |
| Product Code | NHA, PNP | NDP | NDP | NHA | NDP | NDP | NDP |
| 510(k) | K211109 | Exempt | Exempt | n/a (Subject deviceline) | Exempt | Exempt | Exempt |
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5. Indication for Use
NobelProcera® Zirconia Abutment / Implant Crown N1™ Base:
The NobelProcera® Zirconia Abutment/Implant Crown N1™ Base is a patient-matched CAD/CAM prosthetic component directly connected to an endosseous dental implant abutment with the Prosthetic Screw and is indicated for use as an aid in prosthetic rehabilitation.
Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base:
The Prosthetic Screw is to be directly connected to the dental abutment or crown, indicated for use as an aid in prosthetic rehabilitation.
6. Substantial Equivalence
a) Substantial Equivalence NobelProcera® Zirconia Abutment / Implant Crown N1™ Base
Details of the Similarities Between the Subject and Primary Predicate
The similarities between the NobelProcera® Zirconia Abutment / Implant Crown N1™ Base (Subject Device) and the Primary Predicate, On1 Concept (K161655) as described in Table 3 below are as follows:
- The Intended Use and the Indications for Use is the same, expressed through a similar choice of words.
- The device design, the compatible Implant/Base platforms (NP/RP), the device connection/connector, the materials of the connector, the screw access and the device attachment method are identical for the Subject and Primary Predicate. Furthermore, both, the Subject and Primary Predicate are non-sterile, single-use devices. Additionally, the approach for biocompatibility and fatigue testing is the same for the Subject device and Primary Predicate.
Details of the Differences Between the Subject and Primary Predicate
There are no significant differences between the Subject and Primary Predicate but there are minor differences as follows:
- Both, the Subject device and the Primary Predicate utilizes a Ceramic material based on yttria-stabilized tetragonal zirconia (Y-TZP) for the abutment / implant crown material according to ISO 13356. However, for the Subject device a pre-sintered Zirconia milling disk "Nacera Pearl" (FDA cleared Zirconia material cleared under K143071) has been used which is also utilized for the mesostructure as part of Reference No. 1 (Universal Abutment Nobel Biocare N1™ Base Tri and Nobel Biocare N1™ Base Xeal™ TCC Tri as part of N1™ TiUltra™ TCC Implant system; K211109)
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- The design methods including the angulated screw channel dimensions and device dimensions, manufacturing and packaging are similar to Reference Device No. 2. Both devices are patient-matched devices with an individualized emergence profile and shape design. Both devices feature an angulated screw channel with the same screw channel angulation range (0° - 25°).
- -The maximum device body angulation limits of the Subject device is similar to Reference Device No.1 and the difference is substantiated with fatigue testing.
- -However, the Subject device feature two design options, i.e. abutment design and implant crown design, whereas the Primary Predicate device feature only an abutment design option.
These minor differences do not raise new concerns of substantial equivalence. The comparison below (Table 3) for the Subject device, Primary Predicate and Reference Devices demonstrate that the Subject device is substantially equivalent to the Primary Predicate with regards to their Indications for use, technology and performance specifications.
The subject device furthermore does not introduce a fundamentally new scientific technology, and nonclinical performance testing demonstrates that the device is substantially equivalent. The performance testing described in this submission supports the conclusion that the Subject device performs as well as the Primary Predicate device for its intended use.
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| Subject device | Predicate device | Reference device | Reference device | |||
|---|---|---|---|---|---|---|
| Device Characteristics | NobelProcera® ZirconiaAbutment / Implant Crown N1™Base | On1 Concept - K161655(Primary Predicate) | N1™ TiUltra™ TCC Implantsystem (N1™ system) -K211109(limited to Universal AbutmentNobel Biocare N1™ Base Tri &Nobel Biocare N1™ BaseXeal™ TCC Tri)(Reference Device No.1) | Nobel Procera AngulatedScrew Channel AbutmentConical Connection - K132746(Reference Device No. 2) | Comparison | |
| Device | NobelProcera® ZirconiaAbutment / Implant Crown N1™Base | On1 Esthetic Abutment ZirconiaOn1 Base | Universal Abutment NobelBiocare N1™ Base TriNobel Biocare N1™ BaseXeal™ TCC Tri | Nobel Procera Angulated ScrewChannel Abutment ConicalConnections | ||
| PictorialRepresentation | Image: Implant CrownImage: Abutment | Image: On1 Esthetic Abutment ZirconiaImage: On1 Base | Image: Universal Abutment Nobel Biocare N1 Base Tri(including mesostructure(right))Image: Nobel Biocare N1 BaseXeal TCC Tri | Image: Nobel Procera Angulated ScrewChannel Abutment ConicalConnection with Adapter forZirconia Abutment ConicalConnection | ||
| Regulatory Classification | ||||||
| Regulatory ClassReg. Number /Classification name | Class II | Class II | Class II | Class II | Same as Primary Predicate | |
| Subject device | Predicate device | Reference device | Reference device | |||
| Device Characteristics | NobelProcera® ZirconiaAbutment / Implant Crown N1 ™Base | On1 Concept - K161655(Primary Predicate) | N1™ TiUltra™ TCC Implantsystem (N1 ™ system) -K211109(limited to Universal AbutmentNobel Biocare N1™ Base Tri &Nobel Biocare N1 ™ BaseXeal™ TCC Tri)(Reference Device No.1) | Nobel Procera AngulatedScrew Channel AbutmentConical Connection - K132746(Reference Device No. 2) | Comparison | |
| 21 CFR 872.3630Endosseous dental implantabutment | 21 CFR 872.3630Endosseous dental implantabutment | 21 CFR 872.3630Endosseous dental implantabutment | 21 CFR 872.3630Endosseous dental implantabutment | |||
| Product Code | NHA | NHA | NHA, PNP | NHA | Same as Primary Predicate | |
| Indications for Use/Intended Use | ||||||
| Intended Use/Principles of operation | NobelProcera® ZirconiaAbutment / Implant Crown N1 ™Base is a customized dentalprosthetic device which is seatedand attached directly to a dentalimplant abutment to facilitaterestoration.NobelProcera® ZirconiaAbutment / Implant Crown N1™Base is individually designed andmanufactured to fulfill the clinicalneed of each patient. | The On1™ devices areintended for use in the field ofdentistry. They are intended tobe used in the upper or lowerjaw for supporting toothreplacements to restorechewing function and esthetics.The On1™ esthetic abutmentsin combination with the On1™Base on Nobel Biocare ConicalConnection endosseousimplants are indicated forsingle-unit cement retained | Intended to be connected to anendosseous dental implant tosupport the placement of a dentalprosthesis. | Nobel Biocare'sNobelProcera® ASC AbutmentZirconia is a customized dentalabutment. The abutment isseated and attached directly tothe endosseous dental implantand provides a platform forrestoration.The NobelProcera® ASCAbutment Zirconia isindividually designed andmanufactured to fulfill theclinical need of each patient. | Same Indication for Use as PrimaryPredicate expressed through asimilar choice of words | |
| NobelProcera® ZirconiaAbutment / Implant Crown N1 ™Base is made out of Zirconia andis delivered with a Prostheticscrew. | restorations. | The NobelProcera® ASCAbutment Zirconia is made outof Zirconia and is deliveredwith a titanium adapter and anOmnigrip™ clinical screw. | ||||
| Subject device | Predicate device | Reference device | Reference device | Comparison | ||
| Device Characteristics | NobelProcera® ZirconiaAbutment / Implant Crown N1 ™Base | On1 Concept - K161655(Primary Predicate) | N1™ TiUltra™ TCC Implantsystem (N1 ™ system) -K211109(limited to Universal AbutmentNobel Biocare N1™ Base Tri &Nobel Biocare N1™ BaseXeal™ TCC Tri)(Reference Device No.1) | Nobel Procera AngulatedScrew Channel AbutmentConical Connection - K132746(Reference Device No. 2) | Comparison | |
| Indication for Use | The NobelProcera® ZirconiaAbutment / Implant Crown N1 ™Base is a patient-matchedCAD/CAM prosthetic componentdirectly connected to anendosseous dental implantabutment with the ProstheticScrew and is indicated for use asan aid in prosthetic rehabilitation. | The On1™ device is apremanufactured prostheticcomponent directly connected toan endosseous implant and it isintended for use in prostheticrehabilitation. | n/a | The NobelProcera AngulatedScrew Channel Abutment ConicalConnection are premanufacturedprosthetic components directlyconnected to endosseous dentalimplants and is intended for useas an aid in prostheticrehabilitation. | Same Indication for Use as PrimaryPredicate expressed through asimilar choice of words | |
| Technological Characteristics | ||||||
| Device design | 2-piece abutment construct whichconsists of the N1 Base XealTCC Tri (K211109) screw-retained using the ProstheticScrew (subject device Table 4) tothe NobelProcera® ZirconiaAbutment / Implant Crown N1™Base component (subject device) | 2-piece abutment construct whichconsists of the On1 Base screw-retained using the ProstheticScrew to the On1 EstheticAbutment. | 3-piece abutment construct whichconsists of the N1 Base XealTCC Tri (K211109) screw-retained using the ProstheticScrew to the N1 Universal Baseabutment and a cementedretained implant crown portionmade of zirconium oxide. | 2-piece abutment construct whichconsists of the Nobel ProceraAngulated Screw ChannelAbutment made of zirconiumoxide screw-retained through thetitanium Adapter for ZirconiaAbutment Conical Connectionusing the Omnigrip Clinical ScrewConical Connection to theimplant. | Similar to Primary Predicate | |
| CompatibleImplant/Base platformsizes | - Narrow Platform (NP)- Regular Platform (RP) | - Narrow Platform (NP)- Regular Platform (RP)- Wide Platform (WP) | - Narrow Platform (NP)- Regular Platform (RP) | - Narrow Platform (NP)- Regular Platform (RP) | Within the range of the PrimaryPredicate | |
| Device connection /connector | The NobelProcera® ZirconiaAbutment / Implant Crown N1 ™Base component (subject device)is connected to the N1 Base XealTCC Tri (K211109) with the | The On1 Esthetic AbutmentDevice is connected to the On1Base with the On1 ProstheticScrew. | The mesostructure is cementedon top of the Universal AbutmentNobel Biocare N1™ Base andconnected to Nobel Biocare N1 ™Base Xeal™ TCC Tri with the | The Nobel Procera AngulatedScrew Channel Abutment ConicalConnection is connected toAdapter for Zirconia AbutmentConical Connection with the | Same concept as PrimaryPredicate | |
| Device Characteristics | Subject device | Predicate device | Reference device | Reference device | Comparison | |
| NobelProcera® ZirconiaAbutment / Implant Crown N1 ™Base | On1 Concept - K161655(Primary Predicate) | N1™ TiUltra™ TCC Implantsystem (N1™ system) -K211109(limited to Universal AbutmentNobel Biocare N1™ Base Tri &Nobel Biocare N1™ BaseXeal™ TCC Tri)(Reference Device No.1) | Nobel Procera AngulatedScrew Channel AbutmentConical Connection - K132746(Reference Device No. 2) | Comparison | ||
| Prosthetic Screw NobelProcera®Zr Nobel Biocare N1™ Base(subject device in Table 4). | Prosthetic Screw Nobel BiocareN1™ Base. | Omnigrip Clinical Screw ConicalConnection. | ||||
| Connector material | Titanium vanadium alloyMTA 005(Ti6Al4V ELI, ASTM F136 / ISO5832)NOTE: Nobel Biocare N1 ™ BaseXeal™ TCC Tri is not part ofsubject device and only includedfor illustration. This device hasbeen cleared by K211109 (N1™TiUltra™ TCC Implant system(N1™ system)), see Referencedevice No. 1 | Titanium vanadium alloyMTA 005(Ti6Al4V ELI, ASTM F136 / ISO5832) | Titanium vanadium alloyMTA 005(Ti6Al4V ELI, ASTM F136 / ISO5832) | Titanium vanadium alloyMTA 005(Ti6Al4V ELI, ASTM F136 / ISO5832) | Same as Primary Predicate | |
| Mesostructure/ Crownmaterial | Ceramic material based on yttria-stabilized tetragonal zirconia (Y-TZP)Nacera® Pearl Shaded 16+2(K143071) by Doceram MedicalCeramics GmbHBlank manufacturer: DoceramMedical Ceramics GmbH16+2 Shades (A1 to D2) | Ceramic material based on yttria-stabilized tetragonal zirconia (Y-TZP) | Ceramic material based on yttria-stabilized tetragonal zirconia (Y-TZP)Nacera® Pearl Shaded 16+2(K143071) by Doceram MedicalCeramics GmbHBlank manufacturer: DoceramMedical Ceramics GmbH16+2 Shades (A1 to D2) | Ceramic material based on yttria-stabilized tetragonal zirconia (Y-TZP)Zirconia 4 shades (white-intense)by Nobel BiocareBlank manufacturer: NobelBiocare | Similar to Primary PredicateSame as Reference Device No. 1 | |
| Device Characteristics | Subject device | Predicate device | Reference device | Reference device | ||
| NobelProcera® ZirconiaAbutment / Implant Crown N1 ™Base | On1 Concept - K161655(Primary Predicate) | N1™ TiUltra™ TCC Implantsystem (N1™ system) -K211109(limited to Universal AbutmentNobel Biocare N1™ Base Tri & | Nobel Procera AngulatedScrew Channel AbutmentConical Connection - K132746(Reference Device No. 2) | Comparison | ||
| Nobel Biocare N1™ BaseXeal™ TCC Tri)(Reference Device No.1) | ||||||
| The chemical composition isaccording to ISO 13356 "Implantsfor surgery - Ceramic materialbased on yttria-stabilizedtetragonal zirconia (Y-TZP) | The chemical composition isaccording to ISO 13356 "Implantsfor surgery - Ceramic materialbased on yttria-stabilizedtetragonal zirconia (Y-TZP) | The chemical composition isaccording to ISO 13356 "Implantsfor surgery - Ceramic materialbased on yttria-stabilizedtetragonal zirconia (Y-TZP) | 4 Zirconia shades (White tointense).The chemical composition isaccording to ISO 13356 "Implantsfor surgery - Ceramic materialbased on yttria-stabilizedtetragonal zirconia (Y-TZP) | |||
| Screw access | Platform specific ø of the screwhole and ASCNP: 2.9 mmRP: 3.1 mm | Platform specific ø of the screwholeNP/RP/WP: D2.44 mmNo ASC feature | Platform specific ø of the screwholeNP: D2.5 mmRP: D2.7 mmNo ASC feature | Platform specific ø of the screwhole and ASCNP: D2.5 mmRP: D2.65 mm | Similar to Primary Predicate | |
| Emergence profile | Individualized | Standardized | Mesostructure: Individualized | Individualized | Same as Reference Device No. 1 | |
| Individual shapedesign | Individualized | Modifiable | Mesostructure: Individualized | Individualized | Same as Reference Device No. 1 | |
| Attachment method /Device Fixation | Screw retained | Screw retained | Mesostructure: Cemented onUniversal Abutment NobelBiocare N1™ Base Tri | Screw retained | Same as Primary Predicate | |
| Angulated Screwchannel | Yes | No | No | Yes | Same as Reference Device No. 2 | |
| Device dimensions | Maximum:● Diameter/width: 14.8mm | Abutment Width at base● 4.8, 5.3 and 6.5 mm | Device dimensions ofmesostructure: | Maximum (applicable for NP,RP):● Diameter: 20 mm | Similar to Reference devices | |
| Subject device | Predicate device | Reference device | Reference device | |||
| Device Characteristics | NobelProcera® ZirconiaAbutment / Implant Crown N1TMBase | On1 Concept - K161655(Primary Predicate) | N1TM TiUltraTM TCC Implantsystem (N1TM system) -K211109(limited to Universal AbutmentNobel Biocare N1TM Base Tri &Nobel Biocare N1TM BaseXealTM TCC Tri)(Reference Device No.1) | Nobel Procera AngulatedScrew Channel AbutmentConical Connection - K132746(Reference Device No. 2) | Comparison | |
| Height: 16.8 mmMinimum:NP:Min. Post height: 4.2 mm Min. wall thickness: 0.4 mm RP:Min. Post height: 4.2 mm Min. wall thickness: 0.4 mm | Combined base and post height8.2 and 9.0 mm | Maximum (applicable for NP,RP):Diameter: n /a Height: 24.5 mm Minimum:NP:Min. Post height: 5.2 mm Min. wall thickness: 0.5 mm (circular) & 0.35 mm (margin) RP:Min. Post height: 5.2 mm Min. wall thickness:0.5 mm (circular) & 0.35 mm (margin) | Height: 20 mmMinimum:NP:Min. Post height: 3.3 mm Min. wall thickness: 0.4mm RP:Min. Post height: 3.1 mm Min. wall thickness: 0.4 mm | |||
| Screw channelangulation | between 0° to 25° | n/a | n/a | between 0° to 25° | Same as Reference Device No. 2 | |
| Device Characteristics | Subject device | Predicate device | Reference device | Reference device | ||
| Nobel Procera® ZirconiaAbutment / Implant Crown N1 ™Base | On1 Concept - K161655(Primary Predicate) | N1™ TiUltra™ TCC Implantsystem (N1™ system) -K211109(limited to Universal AbutmentNobel Biocare N1™ Base Tri &Nobel Biocare N1™ BaseXeal™ TCC Tri)(Reference Device No.1) | Nobel Procera AngulatedScrew Channel AbutmentConical Connection - K132746(Reference Device No. 2) | Comparison | ||
| Maximum device bodyangulation | Angulation depending on marginheight: | n/a | 20° | n/a | Similar to Reference Device No.1,difference substantiated withfatigue testing | |
| Marginheight | Maximumangulationabovemarginheight (softtissue height)measuredfrom top ofthe implant | |||||
| < 4.4 mm | 30° | |||||
| 5 mm | 27° | |||||
| 6 mm7 mm8 mm | 24°22°19° | |||||
| Manufacturing, Packaging & Reusability | ||||||
| Design Method | Wax-up or CAD | n/a | CAD | Wax-up or CAD | Similar to Reference Device No. 1and same as Reference Device No.2 | |
| Subject device | Predicate device | Reference device | Reference device | |||
| Device Characteristics | NobelProcera® ZirconiaAbutment / Implant Crown N1TMBase | On1 Concept - K161655(Primary Predicate) | N1TM TiUltraTM TCC Implantsystem (N1TM system) -K211109(limited to Universal AbutmentNobel Biocare N1TM Base Tri &Nobel Biocare N1TM BaseXealTM TCC Tri)(Reference Device No.1) | Nobel Procera AngulatedScrew Channel AbutmentConical Connection - K132746(Reference Device No. 2) | Comparison | |
| Manufacturing | Industrialized manufacturing atNobelProcera manufacturingfacility | Pre-manufactured | In-lab milling (dental laboratories) | Industrialized manufacturing atNobelProcera manufacturingfacility | Same as Reference Device No. 2 | |
| Sterilization | Non-sterile | On1 Esthetic Abutment:Non-sterileOn1 Base:Sterile(Gamma sterilization (SAL 10-6)) | Universal Abutment NobelBiocare N1TM Base Tri:Non-sterileNobel Biocare N1TM BaseXealTM TCC Tri:Sterile(Gamma sterilization (SAL 10-6))Mesostructure:Non-sterile | Non-sterile | Same as Primary Predicate | |
| Reusability | Single use | Single use | Single use | Single use | Same as Primary Predicate | |
| Packaging | Primary packaging: TransparentAPET (amorphous polyethyleneterephthalate) clamshell with greypolyester foam inlay inside.Secondary packaging: Cardboardshelf box | On1 Esthetic Abutment:Transparent PETG (polyethyleneterephthalate glycol) blistersealed with medical paper lid.On1 Base: Transparent PETG(polyethylene terephthalateglycol) blister sealed with medicalpaper lid. | Universal Abutment NobelBiocare N1TM Base Tri:Transparent PETG (polyethyleneterephthalate glycol) blistersealed with medical paper lid.Nobel Biocare N1TM Base XealTMTCC Tri:Transparent PETG (polyethyleneterephthalate glycol) blistersealed with medical paper lid. | Primary packaging: TransparentAPET (amorphous polyethyleneterephthalate) clamshell with greypolyester foam inlay inside.Secondary packaging: Cardboardshelf box | Same as Reference Device No. 2 | |
| Device Characteristics | Subject device | Predicate device | Reference device | Reference device | ||
| NobelProcera® ZirconiaAbutment / Implant Crown N1 ™Base | On1 Concept - K161655(Primary Predicate) | N1 ™ TiUltra™ TCC Implantsystem (N1 TM system) -K211109(limited to Universal AbutmentNobel Biocare N1™ Base Tri &Nobel Biocare N1™ BaseXeal™ TCC Tri)(Reference Device No.1) | Nobel Procera AngulatedScrew Channel AbutmentConical Connection - K132746(Reference Device No. 2) | Comparison | ||
| Performance Testing | ||||||
| Fatigue Performance | Fatigue testing according to ISO14801 | Fatigue testing according to ISO14801 | Fatigue testing according to ISO14801 | Fatigue testing according to ISO14801 | Same as Primary Predicate | |
| Biocompatibility | Biocompatible according toISO 10993-1 | Biocompatible according toISO 10993-1 | Biocompatible according toISO 10993-1 | Biocompatible according toISO 10993-1 | Same as Primary Predicate |
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b) Substantial Equivalence Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base
Details of the Similarities Between the Subject and Reference Device No. 1 The similarities between the Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base and the Reference Device No. 1, Prosthetic Screw Nobel Biocare N1™ Base (device line of the N1™ TiUltra™ TCC Implant system (N1™ system)) as described in Table 4 below are as follows:
- The Intended Use statement and Indications for Use statement is the same and expressed through a similar choice of words.
- The Principle of operation, compatible Implant/Base platforms (NP/RP), device material, thread design and screw interfaces are the same for both, Subject device and the Reference Device No. 1.
- -The approach for non-clinical performance testing is the same for the Subject device and Reference Device No. 1 .
Details of the Differences Between the Subject and Reference Device No. 1 There are no significant differences between the Subject and Reference Device No.1 but there are minor differences as follows:
- The Subject device and Reference Device No. 1 have different screw body dimensions including nominal total lengths
- -Both devices. Subject device and Reference Device No. 1. are DLC (Diamond like carbon) coated, however, the screw head of the Subject Device is not anodized in comparison to the Reference Device No. 1.
- The Subject device is provided as non-sterile device to the user whereas the -Reference Device No. 1 is provided as sterile device (Gamma sterilization) to the user. However, Reference Device No. 2 (Omnigrip Clinical Screw CC NP/RP, covered by Nobel Procera Angulated Screw Channel Abutment Conical Connection K1327467) is also provided as non-sterile device.
- -The packaging of the Subject device and Reference Device No. 1 differs in utilized materials and overall packaging set-up.
However, these minor differences do not raise new concerns of substantial equivalence. The comparison below (Table 4) for the Subject device, Reference Device No. 1 and Reference device No. 2 demonstrates that the Subject device is substantially equivalent to the Reference Device No. 1 with regards to their Indications for use, technology, and performance specifications.
The subject device furthermore does not introduce a fundamentally new scientific technology, and nonclinical performance testing demonstrates that the device is substantially equivalent. The performance testing described in this submission supports the conclusion that the Subject device performs as well as the Reference Device No. 1 for its intended use.
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Table 4: NobelProcera® Zirconia Abutment / Implant Crown N1™ Base comparison table
| Subject Device | Reference device | Reference device | Comparison | |
|---|---|---|---|---|
| Device Characteristics | Prosthetic screw NobelProcera® ZrNobel Biocare N1TM Base | N1 TM TiUltraTM TCC Implant system(N1 TM system) - K211109(limited to Prosthetic Screw NobelBiocare N1 TM Base)(Reference Device No. 1) | Nobel Procera Angulated ScrewChannel Abutment ConicalConnection - K1327467(limited to Omnigrip Clinical ScrewCC NP/RP)(Reference Device No. 2) | |
| Device | Prosthetic Screw NobelProcera® ZrNobel Biocare N1TM Base | Prosthetic Screw Nobel Biocare N1 TMBase | Omnigrip Clinical Screw CC NP/RP | |
| Pictorial Representation | Image: NP ScrewImage: RP Screw | Image: NP screwImage: RP screw | Image: NP ScrewImage: RP Screw | |
| Regulatory Classification | ||||
| Regulatory ClassReg. Number /Classification name | Class II21 CFR 872.3630Endosseous dental implant abutment | Class II21 CFR 872.3630Endosseous dental implant abutment | Class II21 CFR 872.3630Endosseous dental implant abutment | Same as Reference Device No.1 |
| Product Code | NHA | NHA | NHA | Same as Reference Device No.1 |
| Indications for Use/Intended Use | ||||
| Intended Use/Principles of operation | The Prosthetic Screw is intended tosecure a dental abutment or frameworkto a dental implant or abutment in theupper or lower jaw and used forsupporting tooth replacements torestore chewing function. | The Clinical and Prosthetic Screw areintended to secure a dental abutment toa dental implant in the upper or lowerjaw and used for supporting toothreplacements to restore chewingfunction. | The Clinical Screw, Abutment Screwand Prosthetic Screw are intended tosecure a dental abutment or frameworkto a dental implant or abutment in theupper or lower jaw and used forsupporting tooth replacements torestore chewing function. | Same as Reference Device No.1 |
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| Device Characteristics | Subject Device | Reference device | Reference device | |||
|---|---|---|---|---|---|---|
| Prosthetic screw NobelProcera® ZrNobel Biocare N1 ™ Base | N1™ TiUltra™ TCC Implant system(N1™ system) - K21109(limited to Prosthetic Screw NobelBiocare N1™ Base)(Reference Device No. 1) | Nobel Procera Angulated ScrewChannel Abutment ConicalConnection - K1327467(limited to Omnigrip Clinical ScrewCC NP/RP)(Reference Device No. 2) | Comparison | |||
| Indications for Use | The Prosthetic Screw is to be directlyconnected to the dental abutment orcrown, indicated for use as an aid inprosthetic rehabilitation | The Clinical and Prosthetic Screw areto be directly connected to the dentalabutment or framework, intended foruse as an aid in prostheticrehabilitation. | N/A | Same Indication for Use asReference Device No. 1 andexpressed through a similarchoice of words | ||
| Technological Characteristics | ||||||
| Principle of operation(Attachment method) | The Prosthetic Screws NobelProcera®Zr NB N1™ Base are used to fix theNobelProcera® Zirconia N1™ BaseAbutment / Implant Crown to the N1Base abutment. | The Prosthetic Screw Nobel BiocareN1™ Base, act as connecting elementsbetween a dental abutments and dentalabutments. The mechanism of action isthrough a mechanical screwconnection." | The Omnigrip clinical screws are usedfor securing the abutment to theendosseous implant. | Same as Reference Device No.1 | ||
| Compatible Implant/Baseplatform sizes | Narrow Platform (NP)Regular Platform (RP) | Narrow Platform (NP)Regular Platform (RP) | Narrow Platform (NP)Regular Platform (RP)Wide Platform (WP) | Same as Reference Device No.1 | ||
| Device material | Titanium vanadium alloyMTA 005(Ti6Al4V ELI, ASTM F136 / ISO 5832) | Titanium vanadium alloyMTA 005(Ti6Al4V ELI, ASTM F136 / ISO 5832) | Titanium vanadium alloyMTA 005(Ti6Al4V ELI, ASTM F136 / ISO 5832) | Same as Reference device No.1 | ||
| Surface material | PVD (DLC) surface treatment(SPE164652) | PVD (DLC) surface treatment(SPE164652) | NP screw: N/A (machined surface, noPVD (DLC) coating)Blue anodization on screw head | Similar as Reference Device No.1 | ||
| No anodization | Anodization (Magenta for NP screw /Yellow for RP screw) | RP screw: PVD (DLC) surfacetreatmentBlue anodization on screw head. |
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| Device Characteristics | Subject Device | Reference device | Reference device | Comparison |
|---|---|---|---|---|
| Prosthetic screw NobelProcera® ZrNobel Biocare N1TM Base | N1TM TiUltraTM TCC Implant system(N1 TM system) - K211109(limited to Prosthetic Screw NobelBiocare N1 TM Base)(Reference Device No. 1) | Nobel Procera Angulated ScrewChannel Abutment ConicalConnection - K1327467(limited to Omnigrip Clinical ScrewCC NP/RP)(Reference Device No. 2) | ||
| Screw body dimensions | Largest nominal diameter:NP: 2.68 mmRP: 2.88 mmNominal total length:NP: 4.54 mmRP: 4.54 mm | Largest nominal diameter:NP: 2.34 mmRP: 2.54 mmNominal total length:NP: 4.8 mmRP: 4.8 mm | Largest nominal diameter:NP: 2.375 mmRP: 2.525 mmNominal total length:NP: 8.905 mmRP: 8.705 mm | Similar to Reference Device No.1 |
| Thread design | NP: M2x0.2 mmRP: M2.2x0.2 mm | NP: M2x0.2 mmRP: M2.2x0.2 mm | NP: M1.6 x 0.35 mmRP: M2 x 0.4 mm | Same as Reference Device No.1 |
| Screw Interface | Omnigrip Mini | Omnigrip Mini | Omnigrip | Same as Reference Device No.1 |
| Manufacturing, Packaging & Reusability | ||||
| Packaging set-up | Primary packaging: Transparentpeelable bag made out of OPA-PEfilm.Secondary packaging: Cardboardjacket with transparent PET(polyethylene terephthalate) window. | Transparent PETG (polyethyleneterephthalate glycol) blister sealedwith medical paper lid. | Transparent PETG (polyethyleneterephthalate glycol) blister sealedwith medical paper lid. | Similar to Reference Device No.1 |
| Duration of use | Permanent Use | Permanent Use | Permanent Use | Same as Reference Device No.1 |
| Sterilization at supply | Non-sterile | Sterile(Gamma sterilization (SAL 10-6)) | Non-sterile | Same as Reference Device No.2 |
| Reusability | Single use | Single use | Single use | Same as Reference Device No.1 |
| Performance Testing | ||||
| Device Characteristics | Subject Device | Reference device | Reference device | Comparison |
| Prosthetic screw NobelProcera® ZrNobel Biocare N1™ Base | N1™ TiUltra™ TCC Implant system(N1™ system) - K211109(limited to Prosthetic Screw NobelBiocare N1™ Base)(Reference Device No. 1) | Nobel Procera Angulated ScrewChannel Abutment ConicalConnection - K1327467(limited to Omnigrip Clinical ScrewCC NP/RP)(Reference Device No. 2) | ||
| Fatigue Performance | Fatigue testing according to ISO 14801 | Fatigue testing according to ISO 14801 | Fatigue testing according to ISO 14801 | Same as Reference Device No. 1 |
| Biocompatibility | Biocompatible according toISO 10993-1 | Biocompatible according toISO 10993-1 | Biocompatible according toISO 10993-1 | Same as Reference Device No. 1 |
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Performance Data:
Non-clinical testing was performed on the Subject device lines NobelProcera® Zirconia Abutment / Implant Crown N1™ Base and Prosthetic Screw NobelProcera® Zr Nobel Biocare N1 ™ Base
- Packaging system performance testing per ASTM D4169
- . Dynamic loading testing performed according to ISO 14801 was conducted according to ISO 14801 and the FDA Guidance Document entitled, "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004). Testing also includes evaluation of the removal torque to assess if any screw-loosening of the run-out samples happened during ISO 14801 cyclic loading.
- Wear assessment of the titanium components/zirconia contact area: ●
- o Assessment of all contacting surfaces of the subject device lines and the contacting surface of the Nobel Biocare N1 ™ Base Xeal™ TCC Tri using Light optical and SEM imaging following fatigue loading test according to ISO 14801 to demonstrate that the subject device lines present similar wear pattern in comparison with reference device systems (i.e. NobelProcera® Zirconia lmplant Bridge (K202452) and NobelProcera® ASC Abutment CC (K132746))
- In addition, real-world evidence on reference devices having DLC-coated prosthetic screw in contact with Zirconia abutments/restorations were reviewed. This real-world evidence according to the FDA Guidance Document entitled "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices" included the following:
- Post-Market Surveillance (PMS) data on NPr ASC Ab Zirconia CC ■ (K132746), collected from December 2013 up to January 2022. In this data set, the longest possible time a Zirconia abutment with a DLC-coated Omnigrip Clinical Screw CC has been in a patient was approximately 8.1 years. The complaint rates were low and well within Nobel Biocare's predefined acceptance criteria and did not raise any concerns regarding the safety and effectiveness of utilizing dissimilar materials
- I Post-Market Surveillance (PMS) data for NobelProcera® Zr Implant Bridge (K202452), collected from May 2020 up to January 2022. In this data set, the longest possible time a Zirconia restoration has been in a patient was approximately 1.7 years. The complaint rates were low and well within Nobel Biocare's predefined acceptance criteria and did not raise any concerns regarding the safety and effectiveness of utilizing dissimilar materials.
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- Clinical Data on NPr ASC Ab Zirconia CC, obtained from 5 [1-5] clinical studies1 reporting on 277 NPr ASC Ab Zirconia CC (K132746) with reported mean follow ups ranging between a mean of 0.6 and 3.6 years. The studies were included consecutively with no selection regarding study inclusion made besides the inclusion criterion that the NPr ASC Ab Zirconia CC had to be used in the study. The clinical endpoints comprised relevant parameters such as soft and hard tissue health, and adverse events. There were no reports of any wear debris stemming from the Zirconia restoration / DLC-coated screw. Nor were other adverse events or other clinical outcomes reported that would raise different questions of safety and effectiveness, for devices using dissimilar materials.
- . 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 support safety and effectiveness for devices using dissimilar materials.
- Magnetic Resonance compatibility testing according to ASTM F2052, ASTM F2213, ● ASTM F2119 and ASTM F2182
- . Verification of biocompatibility of the final device in accordance with ISO 10993-1
- End user cleaning and sterilization validation in in accordance with ISO 17665-1 and ● AAMI TIR12
| [1] Greer, A.C., et al., Mechanical Complications Associated with Angled Screw Channel Restorations. Int J Prosthodont, 2017. 30(3): p. 258-259.
[2] Lv. X.-L., et al., Clinical, radiographic, and immunological evaluation of angulated screw-retained and cemented single-implant crowns in the esthetic region: A 1-year randomized clinical trial. Clinical Implant Dentistry and Related Research, 2021. 23(5): p. 692-702.
[3] Friberg, B. and M. Ahmadzai, A prospective study on single tooth reconstructions using parallel walled implants with internal connection (NobelParallel CC) and abutments with angulated screw channels (ASC). Clin Implant Dent Relat Res, 2019. 21(2): p. 226-231.
[4] Sanz-Martin, I., et al., Soft tissue augmentation at immediate implants using a novel xenogeneic collagen matrix in conjunction with immediate provisions: A prospective case series. Clin Implant Dent Relat Res, 2019. 21(1): p. 145-153.
[5] Fabbri, G., et al., Factors associated with prosthetic complications with individualized abutments: Real-world data [EAO-660], in European Association for Osseointegration Congress. accepted 2022: Geneva.
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7. Conclusion
NobelProcera® Zirconia N1™ Base (premanufactured and patient matched prosthetic components) consisting of the two subject device lines (NobelProcera® Zirconia Abutment / Implant Crown N1™ Base and Prosthetic Screw NobelProcera® Zr Nobel Biocare N1™ Base) are substantially equivalent to the Primary Predicate (On1 Concept – K161655) and Reference Devices (Universal Abutment Nobel Biocare N1™ Base Tri & Nobel Biocare N1™ Base Xeal™ TCC Tri as well as Prosthetic Screw Nobel Biocare N1 ™ Base as part of N1 ™ TiUltra™ TCC Implant system (N1 ™ system) - K211109)).
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)