(141 days)
Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured prosthetic component directly connected to an endosseous dental implant and is indicated for use as an aid in prosthetic rehabilitation for single units and multiple units of up to three units.
The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.
The Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured titanium abutment which can be customized via a validated CAD/CAM workflow in the dental office or dental laboratory to meet patient-specific anatomical requirements. The customization of the subject device is designed using a dental laboratory software and milled in the dental laboratory, using a Computer Aided Design (CAD)/Computer Aided Manufacturing (CAM) machine.
All digitally designed CAD/CAM customizations for the Titanium Abutment Blank Nobel Biocare N1™ TCC are only intended to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.
The subject device has a premanufactured connection for the Nobel Biocare N1 ™ TCC TiUltra implants on one end and a premanufactured connection for the milling blank holder on the other end. These connections are not patient-specific.
The subject device is available for NP and RP implant platforms.
The subject device is used by dental healthcare professionals in dental offices and dental laboratories.
The subject device is composed of titanium vanadium alloy Ti6Al4V ELI (ISO 5832-3, ASTM F136) and features a surface with the same anodization already cleared in K211109.
It is an implantable single use device. The device is provided non-sterile and intended to be sterilized by the user prior to placement in the patient.
The Titanium Abutment Blank Nobel Biocare N1™ TCC is packaged with a Clinical Screw NB N1 TCC.
This document is a 510(k) summary for the Titanium Abutment Blank Nobel Biocare N1™ TCC. It is a premarket notification for a medical device seeking clearance from the FDA, asserting substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of "acceptance criteria" for the overall device. Instead, it details various non-clinical performance tests conducted and indicates that the device met established performance specifications. The "reported device performance" is described through the outcomes of these tests.
However, based on the non-clinical test data section and the comparison table (Table 2), we can infer certain performance aspects that were evaluated against reference points (predicates or standards).
| Characteristic / Test | Acceptance Criteria (Inferred from Predicate/Standards) | Reported Device Performance |
|---|---|---|
| End-User Cleaning and Sterilization | In accordance with FDA Guidance: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance... issued March 17, 2015" | Validation was conducted and met the guidance specifications. |
| Biocompatibility | In accordance with ISO 10993 | Testing was conducted, and no new issues regarding biocompatibility were raised. |
| Fatigue Testing | In accordance with FDA Guidance: "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments", issued May 12, 2004, and demonstrated substantial equivalence to predicate/reference devices. | Testing conducted on the worst-case system demonstrated substantial equivalence to the predicate and reference devices. |
| Software Verification and End-to-end Workflow Validation | Applicable restrictions are in place and cannot be modified by the user; avoidance of damage or modification of implant-abutment connection geometry during milling; locking of restriction zones from user editing. | Validation was completed, demonstrating that applicable restrictions are in place and cannot be modified by the user, and showing avoidance of damage/modification of connection geometry, and locking of restriction zones. |
| MRI Compatibility | MR Conditional classification (leveraged from K212125). | Demonstrated that the subject device is MR Conditional. |
| Minimum Wall Thickness | Similar to predicate (0.4-0.5mm) and existing reference device #2 (0.3mm). | NP 0.38mm; RP 0.49mm, deemed substantially equivalent as demonstrated by fatigue testing. |
| Minimum Gingiva Height | Similar to predicate (0.5mm) and existing reference device #1 (0.3mm). | 0.335mm, deemed substantially equivalent as demonstrated by fatigue testing. |
| Minimum Diameter | Similar to predicate (3.0-6.0mm) and reference device #1 (2.52-6.0mm). | NP Ø3.21mm; RP Ø3.49mm, deemed similar. |
| Minimum Post Height | Similar to predicate (4mm) and reference device #1 (4mm). | 4.05mm, deemed similar. |
| Maximum Abutment Angulation | Similar to predicate (30°/20°) and reference device #1 (30°). | 30°, deemed identical. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the numerical sample sizes for each non-clinical test (e.g., number of abutments for fatigue testing, or number of software test cases). It refers to tests being conducted on "the worst-case system" for fatigue testing.
The data provenance is internal testing conducted by the manufacturer, Nobel Biocare AB. The document does not specify a country of origin for the data itself, but the submitter is based in Sweden. These are retrospective tests conducted to support the premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the document describes non-clinical engineering and performance testing of a physical and software device, not a diagnostic or AI-driven decision support system requiring expert-established ground truth from patient data.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not done. This device is a component for dental implants and does not involve human readers or AI in the context of comparative effectiveness for diagnostic or interpretive tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is primarily relevant for AI/ML-enabled diagnostic or decision-support software. While the device utilizes CAD/CAM software, the "standalone performance" in this context refers to the software's ability to accurately design and a milling machine's ability to accurately produce the customized abutment according to the design parameters and restrictions. The "Software verification and End-to-end workflow validation" addresses this by demonstrating that the software ensures applicable restrictions are in place and cannot be modified by the user, and that damage to the connection geometry is avoided during milling. It implicitly assesses the algorithm's performance within the manufacturing workflow.
7. The Type of Ground Truth Used
For the non-clinical tests described:
- Cleaning and Sterilization: The "ground truth" is adherence to established FDA guidance and validated protocols.
- Biocompatibility: The "ground truth" is compliance with ISO 10993 standards.
- Fatigue Testing: The "ground truth" is compliance with FDA guidance for dental implants and abutments and demonstrated substantial equivalence to the mechanical properties of predicate devices. This involves mechanical testing to failure or for a specified number of cycles under defined loads.
- Software Verification and End-to-end Workflow Validation: The "ground truth" is the established design parameters, manufacturing specifications, and the functionality requirements for the software (e.g., locking restriction zones, avoiding damage to connection geometry). It's based on engineering specifications.
- MRI Compatibility: The "ground truth" is the established MR Conditional specifications from the referenced K212125 clearance.
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical medical device manufactured using a CAD/CAM workflow, not an AI/ML system that requires a "training set" in the conventional sense. The CAD/CAM software would have been developed and validated through its own software lifecycle, but that is distinct from an AI model training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows 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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Nobel Biocare AB Bernice Jim Head of RA Product Development and Marketed Products Vastra Hamngatan 1 Goteborg, Vastra Gotaland SE 411 17 SWEDEN
Re: K223677
Trade/Device Name: Titanium Abutment Blank Nobel Biocare N1™ TCC Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: March 29, 2023 Received: March 29, 2023
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 -S
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) K223677
Device Name
Titanium Abutment Blank Nobel Biocare N1TM TCC
Indications for Use (Describe)
Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured prosthetic component directly connected to an endosseous dental implant and is indicated for use as an aid in prosthetic rehabilitation for single units of up to three units. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.
Type of Use (Select one or both, as applicable)
| 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 shows the logo for Nobel Biocare. On the left is a red square with a white "N" inside. To the right of the square is the text "Nobel Biocare" in black. The word "Nobel" is on the top line and "Biocare" is on the bottom line with a trademark symbol.
510(k) Summary K223677
For Titanium Abutment Blank Nobel Biocare N1™ TCC
1. Submitter Information
Submitter:
Nobel Biocare AB P.O. Box 5190, 402 26 Västra Hamngatan 1 Goteborg, SE-411 17 Sweden
Bernice Jim, PhD
+41 43 211 42 00
27 April 2023
Submitted By:
Nobel Biocare Services AG Balz Zimmermann-Str. 7 8302 Kloten Switzerland
regulatory.affairs.nb@envistaco.com
Nicole Fuchs/Corinne Larke-Grass
| Contact Person: |
|---|
| E-Mail: |
| Telephone number: |
| Prepared by: |
| Date Prepared: |
2. Device Name
Proprietary Name: Titanium Abutment Blank Nobel Biocare N1™ TCC Manufacturer: Nobel Biocare AB Generic/Common Name: Abutment, Implant, Dental, Endosseous Requlation Name: Endosseous Dental Implant Abutment Regulation Number: 21 CFR§872.3630 Regulatory Class: ll Primary Product Code: NHA Secondary Product Code: PNP
3. Predicate Device
Predicate Device Proprietary Name: Manufacturer: Generic/Common Name: Regulation Name: Regulation Number: Regulatory Class: ll Primary Product Code: Secondary Product Code: Clearance:
Reference Device #1 Proprietary Name: Manufacturer:
Elos Accurate® Customized Abutment Elos Medtech Pinol A/S Abutment, Implant, Dental, Endosseous Endosseous Dental Implant Abutment 21 CFR§872.3630 NHA PNP K222044
DESS Dental Smart Solutions Terrats Medical SL
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Image /page/4/Picture/0 description: The image contains the logo for Nobel Biocare. On the left is a red symbol that looks like a stylized letter N. To the right of the symbol is the text "Nobel Biocare" in a simple, sans-serif font. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".
| Generic/Common Name: | Abutment, Implant, Dental, Endosseous |
|---|---|
| Regulation Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR§872.3630 |
| Regulatory Class: | II |
| Primary Product Code: | NHA |
| Clearance: | K222288 |
| Reference Device #2 | |
| Proprietary Name: | NobelProcera Ti Abutment Camlog Platforms |
| Manufacturer: | Nobel Biocare AB |
| Generic/Common Name: | Abutment, Implant, Dental, Endosseous |
| Regulation Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR§872.3630 |
| Regulatory Class: | II |
| Product Code: | NHA |
| Clearance: | K122602 |
| Reference Device #3 | |
| Proprietary Name: | Nobel Biocare Dental Implant Systems Portfolio - MR Conditional |
| Manufacturer: | Nobel Biocare AB |
| Generic/Common Name: | Implant, Dental, Endosseous |
| Regulation Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3640, 21 CFR 872.3630, 21 CFR 872.4120 |
| Regulatory Class: | II |
| Product Code: | DZE, NHA, PNP, DZI |
| Clearance: | K212125 |
| Reference Device #4 | |
| Proprietary Name: | Esthetic Abutments Nobel Biocare N1 ™ |
| Manufacturer: | Nobel Biocare AB |
| Generic/Common Name: | Abutment, Dental, Endosseous |
| Regulation Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR§872.3630 |
| Regulatory Class: | II |
| Product Code: | NHA |
| Clearance: | K220339 |
4. Device Description
The Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured titanium abutment which can be customized via a validated CAD/CAM workflow in the dental office or dental laboratory to meet patient-specific anatomical requirements. The customization of the subject device is designed using a dental laboratory software and milled in the dental laboratory, using a Computer Aided Design (CAD)/Computer Aided Manufacturing (CAM) machine.
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Image /page/5/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red letter N on the left and the words "Nobel Biocare" on the right. The letter N is stylized and made up of two intersecting lines. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".
All digitally designed CAD/CAM customizations for the Titanium Abutment Blank Nobel Biocare N1™ TCC are only intended to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.
The subject device has a premanufactured connection for the Nobel Biocare N1 ™ TCC TiUltra implants on one end and a premanufactured connection for the milling blank holder on the other end. These connections are not patient-specific.
The subject device is available for NP and RP implant platforms.
The subject device is used by dental healthcare professionals in dental offices and dental laboratories.
The subject device is composed of titanium vanadium alloy Ti6Al4V ELI (ISO 5832-3, ASTM F136) and features a surface with the same anodization already cleared in K211109.
It is an implantable single use device. The device is provided non-sterile and intended to be sterilized by the user prior to placement in the patient.
The Titanium Abutment Blank Nobel Biocare N1™ TCC is packaged with a Clinical Screw NB N1 TCC.
| Subject Device | 301511 – Ti AbutmentBlank NB N1 TCC NPØ10 mm | 301512 – Ti AbutmentBlank NB N1 TCC RPØ10 mm |
|---|---|---|
| Maximum abutment angulation | 30° | |
| Minimum screw channel thickness (min. wall thickness) | 0.38mm | 0.49mm |
| Maximum abutment height from implant level | 16mm | |
| Minimum diameter | 3.21mm | 3.49mm |
| Maximum diameter | 9.95mm | |
| Minimum post height | 4.05mm | |
| Maximum post height | 15.665mm | |
| Minimum gingival margin height | 0.335mm | |
| Maximum margin height | 4.6mm |
Table 1: Design Parameters
Principle of Operation / Mechanism of Action
The customized subject device acts as connecting element between a dental implant and a restoration. The mechanism of action is a mechanical screw connection, through the use of a clinical screw, and through a cemented connection to a restoration.
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Image /page/6/Picture/0 description: The image contains the logo for Nobel Biocare. On the left side of the logo is a red symbol that looks like the letter N. To the right of the symbol is the company name, Nobel Biocare, in black font. The word Nobel is on the top line, and Biocare is on the second line with the trademark symbol.
Compatible Devices:
The Titanium Abutment Blanks Nobel Biocare N1™ TCC are compatible with N1™ TiUltra TCC implants.
5. Indications for Use
Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured prosthetic component directly connected to an endosseous dental implant and is indicated for use as an aid in prosthetic rehabilitation for single units and multiple units of up to three units.
The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.
6. Description of Substantial Equivalence
Overall, the subject device has the following substantial equivalences to the predicate device: similar intended use, the same operating principle, incorporates a similar basic design, incorporates the same materials, customizes to fit patient specific anatomical requirements, same methods of sterility and requires a digital dentistry workflow to manufacture at point of care .
Both subject and predicate abutment devices are premanufactured prosthetic components directly connected to the endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation. Therefore, the devices are substantially equivalent in the consideration of intended use and Indications for Use.
The technological differences between the subject and the predicate device do not affect the shared intended use nor raise different questions of substantial equivalence, as demonstrated by non-clinical testing.
Table 2 below shows the substantial equivalence comparison for the subject device.
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Image /page/7/Picture/0 description: The image contains the logo for Nobel Biocare. The logo consists of a red square with a white "N" inside of it. To the right of the square is the text "Nobel Biocare™" in black font.
| Table 2: Titanium Abutment Blank Nobel Biocare N1™ TCC comparison table | |
|---|---|
| ------------------------------------------------------------------------- | -- |
| Characteristic | Subject DeviceTitanium Abutment Blank NobelBiocare N1 TCC | Predicate DeviceElos Accurate® CustomizedAbutment | Reference Device #1DESS Dental Smart Solutions | Reference Device #2NobelProcera Ti AbutmentCamlog Platforms | Comparison |
|---|---|---|---|---|---|
| K223677 | K222044 | K222288 | K122602 | ||
| ProductClassification | Class II | Class II | Class II | Class II | Identical |
| Regulation Number/ Name | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Identical |
| Endosseous Dental ImplantAbutment | Endosseous Dental ImplantAbutment | Endosseous Dental ImplantAbutment | Endosseous Dental ImplantAbutment | Identical | |
| Product Code,primary | NHA | NHA | NHA | NHA | Identical |
| Product Code,secondary | PNP | PNP | N/A | NHA | Identical |
| Review Panel | Dental | Dental | Dental | Dental | Identical |
| Intended Use | Intended to be connected to anendosseous dental implant tosupport the placement of a dentalprosthesis. | Support of a prosthesis to restorechewing function. | -- | -- | Similar intended useas the PrimaryPredicateexpressed througha similar choice ofwords. |
| Characteristic | Subject Device | Predicate Device | Reference Device #1 | Reference Device #2 | Comparison |
| Titanium Abutment Blank NobelBiocare N1 TCC | Elos Accurate® CustomizedAbutment | DESS Dental Smart Solutions | NobelProcera Ti AbutmentCamlog Platforms | ||
| K223677 | K222044 | K222288 | K122602 | ||
| Indications for Use | Titanium Abutment Blank NobelBiocare N1™ TCC is apremanufactured prostheticcomponent directly connected toan endosseous dental implant andis indicated for use as an aid inprosthetic rehabilitation for singleunits and multiple units of up tothree unitsThe system integrates multiplecomponents of the digital dentistryworkflow: scan files from Intra-OralScanners, CAD software, CAMsoftware, milling machine andassociated tooling and accessories | The Elos Accurate® CustomizedAbutments are intended forattaching to dental implants inorder toprovide basis for single or multipletooth prosthetic restorations. TheElos Accurate® CustomizedAbutment will be attached to adental implant using the includedElos Prosthetic screw.The Elos Accurate® CustomizedAbutments are compatible with theimplant systems listed in Table 1:All digitally designed CAD/CAMcustomizations for the ElosAccurate® Customized Abutmentsare onlyintended to be designed andmanufactured according to digitaldentistry workflow. The workflowsystem integrates multiplecomponents of the digital dentistryworkflow: scan files from Intra-OralScanners, CAD software, CAMsoftware, milling machine andassociated tooling andaccessories. | DESS Dental Smart Solutionsabutments are intended to be usedin conjunction with endosseousdental implants in the maxillary ormandibular arch to provide supportfor prosthetic restorations.All digitally designed customabutments for use with Ti Baseabutments or Pre-milled Blankabutments are to be sent to aTerrats Medical validated millingcenter for manufacture. | The NobelProcera Ti AbutmentsCamlog Platforms arepremanufactured prostheticcomponents directly connected toendosseous dental implants andareintended for use as an aid inprosthetic rehabilitation. They arecompatible with the Camlog Kseries 3.3, 3.8, 4.3, 5.0 and 6.0implants. | Similar Indicationsfor Use as thePrimary Predicateexpressed througha similar choice ofwords. |
| Minimum wallthickness: | NP 0.38mmRP 0.49mm | 0.4 - 0.5mm (Implant Platformdependent) | 0.45mm | 0.3mm-- | Similar as referencedevice #2.Substantialequivalence, asdemonstrated byfatigue testing. |
| Characteristic | Subject Device | Predicate Device | Reference Device #1 | Reference Device #2 | |
| Titanium Abutment Blank NobelBiocare N1 TCC | Elos Accurate® CustomizedAbutment | DESS Dental Smart Solutions | NobelProcera Ti AbutmentCamlog Platforms | Comparison | |
| K223677 | K222044 | K222288 | K122602 | ||
| Minimum gingivaheight: | 0.335 mm | 0.5mm | 0.3mm | -- | Similar as referencedevice #1.Substantialequivalence, asdemonstrated byfatigue testing. |
| Minimum diameter | NP Ø3.21mmRP Ø3.49mm | 3.0 - 6.0 mm (Implant Platformdependent) | 2.52 - 6.0 mm (Implant Platformdependent) | -- | Similar |
| Minimum postheight: | 4.05mm | 4mm | 4mm | -- | Similar |
| Abutment Shape | Patient specific | Patient specific | Patient specific | Patient Specific | Identical |
| Platformcompatibility | Narrow Platform (NP)Regular Platform (RP) | Narrow Platform (NP)Regular Platform (RP) | Narrow Platform (NP)Regular Platform (RP) | 3.3, 3.8, 4.3, 5.0, 6.0 | Identical |
| Attachmentmethod to implant | Screw retained | Screw retained | Screw retained | Screw retained | Identical |
| Prosthesisattachment method | Cement retained | Cement retained | Screw or cement retained | Cement retained | Identical |
| Restoration type | Single-unit and multi-unit (up to 3units) | Single-unit and multi-unit | Single-unit and multi-unit | Single-unit | Similar |
| Design features | Pre-manufactured implant-interface connection, customizablecylindrical abutment body | Pre-manufactured implant-interface connection, customizablecylindrical abutment body | -- | Pre-manufactured implant-interface connection, customizablecylindrical abutment body | Identical |
| Principle ofoperation/Mechanism ofaction | Mechanical screw connection | Mechanical screw connection | -- | Mechanical screw connection | Identical |
| Characteristic | Subject Device | Predicate Device | Reference Device #1 | Reference Device #2 | Comparison |
| Titanium Abutment Blank NobelBiocare N1 TCC | Elos Accurate® CustomizedAbutment | DESS Dental Smart Solutions | NobelProcera Ti AbutmentCamlog Platforms | ||
| K223677 | K222044 | K222288 | K122602 | ||
| Maximumabutmentangulation | 30° | 30°/20° depending on the implantplatform | 30° | 0° | Identical |
| Material | Ti6Al4V ELI (ISO 5832-3, ASTMF136) | Ti6Al4V ELI (ISO 5832-3, ASTMF136) | Ti6Al4V ELI (ISO 5832-3, ASTMF136) | CP TitaniumTitanium/vanadium alloy | Identical |
| Design Workflow | Kavo LS3, 3Shape Trios or otherscanners with equal or higheraccuracy than 6.9 µm3Shape Abutment DesignerSoftware (3Shape A/S) -K151455AbutmentCAD (ExoCAD) -K193352DTX Studio design (Nobel BiocareUSA LLC) - K181932 | 3Shape scanner (3Shape A/S)3Shape Abutment DesignerSoftware (3Shape A/S) -K151455 | -- | Procera System Software(K053602) | Similar to predicate.Substantialequivalence, asdemonstrated bysoftware verificationand end-to-endworkflow validation |
| ManufacturingWorkflow | CORITEC by imes-icore | CORITEC by imes-icore | -- | -- | Identical |
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Image /page/8/Picture/0 description: The image contains the logo for Nobel Biocare. On the left is a red symbol that looks like a stylized letter N. To the right of the symbol is the text "Nobel Biocare" with the trademark symbol next to it. The text is in a simple, sans-serif font.
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Image /page/9/Picture/0 description: The image contains the logo for Nobel Biocare. The logo consists of a red square with a stylized "N" inside of it. To the right of the square is the text "Nobel Biocare" in black font. The word "Nobel" is above the word "Biocare".
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Image /page/10/Picture/0 description: The image contains the logo for Nobel Biocare. On the left is a red square with a stylized white "N" inside. To the right of the square are the words "Nobel" on top and "Biocare" on the bottom, with a trademark symbol after the word Biocare.
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Image /page/11/Picture/0 description: The image contains the logo for Nobel Biocare. The logo consists of a stylized red letter "N" on the left, followed by the words "Nobel" and "Biocare" stacked on top of each other on the right. The "Biocare" text has a trademark symbol next to it.
7. Non-Clinical Test Data
The following performance tests were submitted in this 510(k) to support substantial equivalence and demonstrate that the subject device is as safe and as effective as its predicate device:
- End user cleaning and sterilization validation was conducted in . accordance with Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, issued March 17, 2015 on the subject device.
- . Biocompatibility testing was conducted in accordance with ISO 10993 on the subject device and no new issues regarding biocompatibility were raised for the subject device.
- . Fatique Testing was conducted on the worst-case system of the subject device and leveraged from K220339 in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments", issued May 12, 2004, to demonstrate the subject device is substantially equivalent to the predicate and reference devices.
- Software verification and End-to-end workflow validation was completed . on the subject device with the compatible software and designated workflows to demonstrate that applicable restrictions are in place and cannot be modified by the user. To address the potential risk of damage to the implant-abutment connection geometry during the milling of the patient-matched portions of the abutment blanks, validation testing of CAM restriction zones was conducted on the subject device, including verification to show avoidance of damage or modification of the connection geometry, and locking of restriction zones from user editing in the CAM software.
- . MRI compatibility was leveraged from K212125 to demonstrate that the subject device is MR Conditional.
In conclusion, the results of the non-clinical testing demonstrated that the Titanium Abutment Blank N1™ TCC met the established performance specifications per intended use. The non-clinical testing also demonstrated that the Titanium Abutment Blank N1™ TCC does not raise different questions of substantial equivalence when compared to the respective predicate devices.
8. Clinical Performance Data
Clinical data was not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterized all performance aspects of the Subject Device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this device.
9. Conclusion
The Titanium Abutment Blank Nobel Biocare N1™ TCC was evaluated for substantial equivalence using standard and/or comparative testing. Based on a comparison of
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Image /page/12/Picture/0 description: The image contains the logo for Nobel Biocare. On the left is a red square with a stylized white "N" inside. To the right of the square are the words "Nobel Biocare" stacked on top of each other in black font. The "Biocare" has a trademark symbol next to it.
intended use, Indications for Use, material composition, technological characteristics, features, and performance data the Titanium Abutment Blank Nobel Biocare N1 ™ TCC is at least as safe and effective as the predicate devices, and substantial equivalence to the predicate device is therefore supported.
§ 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.)