(221 days)
Esthetic Abutment Nobel Biocare N1™ TCC: The Esthetic Abutment Nobel Biocare N1™ TCC is a pre-manufactured component directly connected to an endosseous dental implant and is indicated for use as an aid in single unit prosthetic rehabilitation. Esthetic Abutment Nobel Biocare N1TM Base: The Esthetic Abutment Nobel Biocare N1™ Base is a pre-manufactured component connected to an endosseous dental implant and is indicated for use as an aid in single unit prosthetic rehabilitation.
Esthetic Abutments Nobel Biocare N1™ are pre-manufactured dental implant abutments, intended for use as an aid in prosthetic rehabilitation. Esthetic Abutments Nobel Biocare N1™ are intended for use in the upper and/or lower jaw in combination with Nobel Biocare's Nobel Biocare N1™ implant system in order to restore patient esthetics and chewing function to partially or fully edentulous patients. The abutments are made from titanium vanadium allov. Esthetic Abutments Nobel Biocare N1 ™ is composed of two device lines: Esthetic Abutment Nobel Biocare N1™ TCC and Esthetic Abutment Nobel Biocare N1™ Base.
The acceptance criteria and device performance for the Nobel Biocare N1™ Esthetic Abutments are described based on the provided FDA 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Standard / Guidance) | Reported Device Performance |
|---|---|---|
| Mechanical Strength (Fatigue) | ISO 14801 and FDA Guidance Document: "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004) | The tests demonstrated the Subject Devices are substantially equivalent to the Primary Predicate Device and Reference Device #1 (for TCC abutments) and to Predicate Device #2 and Reference Device #1 (for Base abutments). The Subject Device met the performance specifications. |
| Magnetic Resonance (MR) Compatibility | ASTM F2052, ASTM F2213, ASTM F2119, ASTM F2182 | MR Conditional |
| Biocompatibility | ISO 10993-1:2018 Biological Evaluation of Medical Devices | Biocompatible |
| Cleaning and Sterilization | ISO 17665-1 and AAMI TIR12 | Validation performed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test. However, it mentions that dynamic loading (fatigue) testing was conducted in saline at 37 °C. The data provenance is from non-clinical testing, therefore not involving human subjects or data from a specific country of origin in the context of clinical studies. The testing was performed in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The reported performance data for this device (dental abutments) is based on non-clinical, laboratory-based testing (mechanical, MRI compatibility, biocompatibility, cleaning/sterilization), rather than expert assessment of clinical data or images to establish a "ground truth."
4. Adjudication Method for the Test Set
Not applicable. As the testing mentioned is non-clinical and laboratory-based, an adjudication method in the context of human assessment is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical dental abutment, not a diagnostic or AI-assisted interpretation system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical dental abutment, not an algorithm or software. The performance evaluations are of the physical product's characteristics.
7. The Type of Ground Truth Used
The "ground truth" for the performance criteria is established by adherence to recognized international and FDA standards for medical device testing. For example:
- Mechanical strength: Conformance to force/stress limits defined by ISO 14801.
- MRI compatibility: Conformance to safety and performance specifications outlined in ASTM F2052, F2213, F2119, F2182.
- Biocompatibility: Conformance to safety requirements defined by ISO 10993-1.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical medical device, not an AI/ML algorithm.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes 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: K220339
Trade/Device Name: Esthetic Abutments Nobel Biocare N1TM Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 19, 2022 Received: August 19, 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Esthetic Abutments Nobel Biocare N1 TM
Indications for Use (Describe)
Esthetic Abutment Nobel Biocare N1™ TCC:
The Esthetic Abutment Nobel Biocare N1™ TCC is a pre-manufactured component directly connected to an endosseous dental implant and is indicated for use as an aid in single unit prosthetic rehabilitation.
Esthetic Abutment Nobel Biocare N1TM Base:
The Esthetic Abutment Nobel Biocare N1™ Base is a pre-manufactured component connected to an endosseous dental implant and is indicated for use as an aid in single unit 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 shows the logo for Nobel Biocare. The logo consists of a red stylized letter N on the left and the words "Nobel Biocare" on the right. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".
510(k) Summary – K220339
Esthetic Abutments Nobel Biocare N1 ™
i. Submitter Information
Device Class:
Product Code:
| Submitter: | Nobel Biocare ABVastra Hamngatan 1Goteborg 411 17Sweden | |
|---|---|---|
| Submitted By: | Nobel Biocare Services AGBalz-Zimmerman-Strasse 78302 KlotenSwitzerland | |
| Contact Person:E-Mail:Telephone Number:Prepared By:Date Prepared | Bernice Jim, Ph.Dregulatory.affairs@nobelbiocare.com+41 79 855 00 73Heather Yates14 September 2022 | |
| ii. Device Name | ||
| Proprietary name:Manufacturer:Common Name:Classification Name:Regulation Number: | Esthetic Abutments Nobel Biocare N1TMNobel Biocare ABDental AbutmentEndosseous Dental Implant Abutment21 CFR§872.3630 |
ll
NHA
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Image /page/4/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 "TM" symbol is present next to the word "Biocare".
iii. Predicate Devices
Primary Predicate Device
| Propriety Name: | NobelActive Internal Connection Implant (K071370) |
|---|---|
| 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: | DZE, NHA |
Predicate Device #2
| 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 #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 #2
| Proprietary Name: | Nobel Biocare Dental Implant Systems Portfolio – MRConditional (K212125) |
|---|---|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Implants |
| Classification Name: | Endosseous Dental Implant and Abutment |
| Regulation Number: | 21 CFR 872.3640, 21 CFR 872.3630, 21 CFR 872.4120 |
| Regulatory Class: | II |
| Product Code: | DZE, NHA, PNP, DZI |
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Image /page/5/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red stylized letter N on the left, followed by the words "Nobel Biocare" in black text on the right. The word "Nobel" is on the top line, and the word "Biocare" is on the bottom line, with a small "TM" symbol next to it.
iv. Device Description
Device Description
Esthetic Abutments Nobel Biocare N1™ are pre-manufactured dental implant abutments, intended for use as an aid in prosthetic rehabilitation. Esthetic Abutments Nobel Biocare N1™ are intended for use in the upper and/or lower jaw in combination with Nobel Biocare's Nobel Biocare N1™ implant system in order to restore patient esthetics and chewing function to partially or fully edentulous patients. The abutments are made from titanium vanadium allov.
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 Esthetic Abutments Nobel Biocare N1™ 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.
Esthetic Abutments Nobel Biocare N1 ™ is composed of two device lines.
- Esthetic Abutment Nobel Biocare N1™ TCC ●
- Esthetic Abutment Nobel Biocare N1™ Base ●
| Device Line | Connection | Angulation | Platform | Post Height |
|---|---|---|---|---|
| Esthetic Abutment NobelBiocare N1TM | TCC | straight (0°), 15° | NP, RP | 1.75 mm, 3mm |
| Esthetic Abutment NobelBiocare N1TM | Base | straight (0°) | NP, RP | 0.5mm |
Table 5-1 - Accessory/Device List for Esthetic Abutment Nobel Biocare N1™ TCC
Esthetic Abutment Nobel Biocare N1™ TCC:
The Esthetic Abutment Nobel Biocare N1™ TCC are available in NP/RP platforms, with both straight and 15° angulation and 1.75 and 3mm heights available. The devices connect to a dental implant via a tri-oval conical connection (TCC), which is characterized by a trioval-shaped coronal zone and a round, moderately tapered body, and secured with a clinical screw. It is possible to modify the total height of the abutment in the dental laboratory. The 3mm abutments have a total height of 9.5 mm and can be modified to a minimum of 7.1 mm. The 1.75 mm abutments have a total height of 8mm and can be modified to a minimum of 5.6 mm.
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Image /page/6/Picture/0 description: The image contains the logo for Nobel Biocare. The logo consists of a red square with a stylized white "N" inside of it. To the right of the square is the text "Nobel Biocare" in black font, with the "TM" symbol in a smaller font size.
Esthetic Abutment Nobel Biocare N1™ Base:
The Esthetic Abutment Nobel Biocare N1™ Base is available in two platforms (NP and RP). This device line is available as a straight abutment only, no angulated version is available. The devices connect to a dental implant by direct engagement and are secured with a prosthetic screw. It is possible to modify the total height of the abutment in the dental laboratory from 6.45 mm total height to a minimum of 4.5 mm.
v. Principle of Operation / Mechanism of Action
Esthetic Abutment Nobel Biocare N1 ™ TCC
Esthetic Abutment Nobel Biocare N1™ TCC can be directly connected to Nobel Biocare's Nobel Biocare N1™ TCC implants and and retained by a clinical screw, with which they are co-packed, using an Omnigrip Screwdriver. The Nobel Biocare's Nobel Biocare N1 ™ TCC implants and clinical screw were previously cleared in K211109.
Esthetic Abutment Nobel Biocare N1 ™ Base
The Esthetic Abutment Nobel Biocare N1™ Base can be connected to the Nobel Biocare N1™ Base Xeal™ (previously cleared, K211109) via a prosthetic screw, with which it is co-packed and secured using the Omnigrip. The Nobel Biocare N1™ is in turn connected to a Nobel Biocare N1 ™ TCC implant using a clinical screw.
The Esthetic Abutment Nobel Biocare N1™ Base has no direct interaction with either the implant, nor the clinical screw but they do form part of the final construct.
The N1™ Base Xeal™, prosthetic screw, Nobel Biocare N1™ TCC implants, clinical screw were previously cleared in K211109.
vi. Compatible Devices and accessories
The Esthetic Abutment Nobel Biocare N1™ TCC and Esthetic Abutment Nobel Biocare N1™ Base are intended to be used with the following previously cleared or exempt accessories/devices from Nobel Biocare below.
Esthetic Abutment Nobel Biocare N1™ TCC
The N1™ Esthetic Abutment Nobel Biocare N1™ TCC is intended to be used with the following exempt accessories/devices from Nobel Biocare.
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Image /page/7/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red square with a stylized white "N" inside of it. To the right of the square is the text "Nobel Biocare" in black font, with "Nobel" on top of "Biocare" and a small "TM" symbol next to "Biocare".
| ArticleNo. | Product Name | ProductCode | Regulation# | 510(k)Clearance |
|---|---|---|---|---|
| 300852 | Screwdriver Machine Omnigrip Mini 20mm | NDP | 872.3980 | EXEMPT |
| 300853 | Screwdriver Machine Omnigrip Mini 28mm | NDP | 872.3980 | EXEMPT |
| 300854 | Screwdriver Machine Omnigrip Mini 36mm | NDP | 872.3980 | EXEMPT |
| 300855 | Screwdriver Manual Omnigrip Mini 20mm | NDP | 872.3980 | EXEMPT |
| 300856 | Screwdriver Manual Omnigrip Mini 36mm | NDP | 872.3980 | EXEMPT |
| 300921 | Abutment Retrieval Tool NB N1 TCC NP | NDP | 872.3980 | EXEMPT |
| 300922 | Abutment Retrieval Tool NB N1 TCC RP | NDP | 872.3980 | EXEMPT |
| 300962 | Implant Replica NB N1 TCC NP | NDP | 872.3980 | EXEMPT |
| 300963 | Implant Replica NB N1 TCC RP | NDP | 872.3980 | EXEMPT |
| 300964 | IOS Implant Replica NB N1 TCC NP | NDP | 872.3980 | EXEMPT |
| 300965 | IOS Implant Replica NB N1 TCC RP | NDP | 872.3980 | EXEMPT |
| 300972 | Lab Screw NB N1 TCC NP | NDP | 872.3980 | EXEMPT |
| 300973 | Lab Screw NB N1 TCC RP | NDP | 872.3980 | EXEMPT |
| 300968 | Clinical Screw Nobel Biocare N1™ TCC NP | NHA | 872.3980 | K211109 |
| 300969 | Clinical Screw Nobel Biocare N1™ TCC RP | NHA | 872.3980 | K211109 |
| 300857 | Nobel Biocare N1™ TiUltra™ TCC NP3.5x9mm | DZE | 872.3640 | K211109 |
| 300858 | Nobel Biocare N1™ TiUltra™ TCC NP3.5x11mm | DZE | 872.3640 | K211109 |
| 300859 | Nobel Biocare N1™ TiUltra™ TCC NP3.5x13mm | DZE | 872.3640 | K211109 |
| 300860 | Nobel Biocare N1™ TiUltra™ TCC RP4.0x7mm | DZE | 872.3640 | K211109 |
| 300861 | Nobel Biocare N1™ TiUltra™ TCC RP4.0x9mm | DZE | 872.3640 | K211109 |
| 300862 | Nobel Biocare N1™ TiUltra™ TCC RP4.0x11mm | DZE | 872.3640 | K211109 |
| 300863 | Nobel Biocare N1™ TiUltra™ TCC RP4.0x13mm | DZE | 872.3640 | K211109 |
| Article | Product Name | Product Code | Regulation # | 510(k) Clearance |
| 300852 | Screwdriver Machine Omnigrip Mini 20mm | NDP | 872.3980 | EXEMPT |
| 300853 | Screwdriver Machine Omnigrip Mini 28mm | NDP | 872.3980 | EXEMPT |
| 300854 | Screwdriver Machine Omnigrip Mini 36mm | NDP | 872.3980 | EXEMPT |
| 300855 | Screwdriver Manual Omnigrip Mini 20mm | NDP | 872.3980 | EXEMPT |
| 300856 | Screwdriver Manual Omnigrip Mini 36mm | NDP | 872.3980 | EXEMPT |
| 301021 | Base Replica NB N1 Base Tri NP | NDP | 872.3980 | EXEMPT |
| 301022 | Base Replica NB N1 Base Tri RP | NDP | 872.3980 | EXEMPT |
| 301024 | IOS Base Replica NB N1 Base Tri NP | NDP | 872.3980 | EXEMPT |
| 301025 | IOS Base Replica NB N1 Base Tri RP | NDP | 872.3980 | EXEMPT |
| 301033 | Lab Screw NB N1 Base NP | NDP | 872.3980 | EXEMPT |
| 301034 | Lab Screw NB N1 Base RP | NDP | 872.3980 | EXEMPT |
| 301029 | Prosthetic Screw Nobel Biocare N1™ Base NP | NHA | 872.3630 | K211109 |
| 301030 | Prosthetic Screw Nobel Biocare N1™ Base RP | NHA | 872.3630 | K211109 |
| 300982 | Nobel Biocare N1™ Base Xeal™ TCC Tri NP1.75mm | NHA | 872.3630 | K211109 |
| 300983 | Nobel Biocare N1™ Base Xeal™ TCC Tri NP2.5mm | NHA | 872.3630 | K211109 |
| 300984 | Nobel Biocare N1™ Base Xeal™ TCC Tri NP3.5mm | NHA | 872.3630 | K211109 |
| 300985 | Nobel Biocare N1™ Base Xeal™ TCC Tri RP1.75mm | NHA | 872.3630 | K211109 |
| 300986 | Nobel Biocare N1™ Base Xeal™ TCC Tri RP2.5mm | NHA | 872.3630 | K211109 |
| 300987 | Nobel Biocare N1™ Base Xeal™ TCC Tri RP3.5mm | NHA | 872.3630 | K211109 |
Table 5-2 – Accessory/Device List for Esthetic Abutment Nobel Biocare N1 ™ TCC
Esthetic Abutment Nobel Biocare N1 ™ Base
The N1™ Esthetic Abutment Nobel Biocare N1™ Base is intended to be used with the following exempt accessories/devices from Nobel Biocare.
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Image /page/8/Picture/0 description: The image shows 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, with "Nobel" on top of "Biocare".
Table 5-3 – Accessory/Device List for Esthetic Abutment Nobel Biocare N1™ Base
vii. Patient Contacting Components
Following the assessment set forth in ISO 10993-1:2018 Biological Evaluation of Medical Devices, Annex A, it was determined that the devices in scope of this submission do contain patient contacting components. The patient contacting components have direct patient contact components for a permanent duration of time (>30 days).
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Image /page/9/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red square with a stylized white "N" inside of it. To the right of the square is the text "Nobel Biocare" in black font, with "Nobel" on top and "Biocare" below it. The TM symbol is in superscript next to Biocare.
| Product Line | Name Device | Material Description | Colorant |
|---|---|---|---|
| Esthetic Abutment | Nobel | Titanium-6 Aluminum-4 Vanadium alloy: 90% Ti, 6% Al, 4% V (ASTM F136 and ISO 5832-3) + Anodization | N/A |
| Biocare N1TM TCC | |||
| Esthetic Abutment | Nobel | Titanium-6 Aluminum-4 Vanadium alloy: 90% Ti, 6% Al, 4% V (ASTM F136 and ISO 5832-3) + Anodization | N/A |
| Biocare N1TM Base |
Table 5-4 – Patient Contacting Materials
viii. Indications for Use
Esthetic Abutment Nobel Biocare N1 ™ TCC:
The Esthetic Abutment Nobel Biocare N1 TCC is a pre-manufactured component directly connected to an endosseous dental implant and is indicated for use as an aid in single unit prosthetic rehabilitation.
Esthetic Abutment Nobel Biocare N1™ Base:
The Esthetic Abutment Nobel Biocare N1 Base is a pre-manufactured component connected to an endosseous dental implant and is indicated for use as an aid in single unit prosthetic rehabilitation.
ix. Substantial Equivalence - Device Line: Esthetic Abutments Nobel Biocare N1™ TCC
Details of the Similarities between the Subject and Primary Predicate Devices
The similarities between the Subject device line Esthetic Abutments Nobel Biocare N1 ™ TCC and the Primary Predicate Device as described in
Table 5-5 are as follows:
- The Intended Use/Principle of Operation of the Subject Device and the Primary ● Predicate Device are the same, with the only differences being the choice of similar wording. Both devices are used for supporting tooth replacements to restore chewing function. Furthermore, the Subject Device has the same Intended Use/Principle of operation as Reference Device #1.
- The Indications for Use of the Subject device and the Primary Predicate Device is ● the same and expressed through a similar choice of words. Both devices are premanufactured prosthetic components that are directly connected to endosseous dental implants. as an aid in prosthetic rehabilitation.
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Image /page/10/Picture/0 description: The image shows 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, with the word "Nobel" stacked on top of the word "Biocare" and a trademark symbol next to the word "Biocare".
- The macro design and characteristics of the Subject device and the Primary Predicate Device are identical. Both devices are screw retained devices 1-piece abutments made from titanium vanadium alloy (Ti6Al4V ELI according to ASTM F136 and ISO 5832-3 with an anodization surface treatment.
- Both, the Subject Device, and the Primary Predicate Device are manufactured at ● the same Nobel Biocare centralized manufacturing facility utilizing the same manufacturing technology
- . Both, the Subject Device, and the Primary Predicate Device connect directly to the implant and support both Narrow (NP) and Regular Platform (RP) and available in both straight and angulated profiles.
- The surface topography of the Subject Device and the Primary Predicate Device ● #1 are identical on the abutment surface. However, the connection area has the same surface topography as Reference Device #1. The differences do not raise new questions of substantial equivalence, as demonstrated by the performance testing.
- Both, the Subject Device, and the Primary Predicate Device are labelled MR ● Conditional. The Reference Device #2 (K212125) is included for reference to all MRI compatibility.
- The approach for non-clinical performance testing is the same for the Subject ● device and the Subject Device, and the Primary Predicate Device with the same fatigue limits for the two platforms. Testing was furthermore conducted to confirm that the technological differences between the devices do not raise different questions of substantial equivalence. The results of these tests support the Subject Device met the performance specifications and performed as intended.
Details of the differences between the Subject and Primary Predicate Devices:
There are no major differences however there are minor differences between the subject device and the Primary Predicate/Reference Device #1 such as:
- The Subject Device is connected to the implant via a tri-oval conical connection, whereas the Primary Predicate Device is connected via a conical connection.
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Image /page/11/Picture/0 description: The image shows 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 word "Nobel" is in a larger, bolder font than the word "Biocare", and the letters "TM" are in superscript after the word "Biocare".
This difference does not affect the shared intended use, between the devices as demonstrated by non-clinical testing. The same connection (Trioval Conical Connection), with the same dimensions has been used for Reference Device #1.
- The device dimensions are different in the Subject Device and Primary Predicate Device. However, the maximum and minimum device dimensions are within the range of the Primary Predicate Device and Reference Device. Dynamic fatigue test for endosseous dental implants to the FDA Guidance document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" was conducted in saline at 37 °C. The tests demonstrated the Subject Devices are substantially equivalent to the Primary Predicate Device and Reference Device #1.
Conclusion:
Based on a comparison of intended use, indications for use, technological characteristics, principle of operation, features, and performance data, the Esthetic Abutment Nobel Biocare N1™ TCC is deemed to be substantially equivalent to the Primary Predicate Device as it satisfies all criteria of substantial equivalence and does not raise new concerns regarding substantial equivalence: Indications for Use, Technological Characteristics and Performance Data. The new device does not introduce a fundamentally new scientific technology and the nonclinical tests demonstrate that the device is substantial equivalent.
| DescriptiveInformation | Subject DeviceEsthetic AbutmentsNobel Biocare N1 ™TCC | Primary PredicateDeviceNobelActive InternalConnection Implant –K071370(limited to EstheticAbutment ConicalConnection) | Reference Device #1N1 ™ TiUltra™ TCCImplant system (N1 ™system) - K211109(limited to UniversalAbutment NobelBiocare N1 ™ TCC) | Comparison |
|---|---|---|---|---|
| Manufacturer | Nobel Biocare AB | Nobel Biocare AB | Nobel Biocare AB | Same |
| PictorialRepresentation | Image: Esthetic Abutments Nobel Biocare N1 TCC | Image: NobelActive Internal Connection Implant | Image: N1 TiUltra TCC Implant system | N/A |
| Regulatory Classification | ||||
| DescriptiveInformation | Subject DeviceEsthetic AbutmentsNobel Biocare N1 ™TCC | Primary PredicateDeviceNobelActive InternalConnection Implant -K071370(limited to EstheticAbutment ConicalConnection) | Reference Device #1N1™ TiUltra™ TCCImplant system (N1 ™system) - K211109(limited to UniversalAbutment NobelBiocare N1™ TCC) | Comparison |
| Regulation # | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Same |
| Regulation Title | Endosseous dentalimplant abutment | Endosseous dentalimplant abutment | Endosseous dentalimplant abutment | Same |
| Regulation Class | II | II | II | Same |
| Product Code | NHA | NHA | NHA | Same |
| Indications for Use/Intended Use | ||||
| Intended Use | Intended to beconnected to anendosseous dentalimplant to support theplacement of a dentalprosthesis. | The NobelActiveEndosseous DentalImplants are intended tobe placed in the upper orlower jaw to supportprosthetic devices suchas artificial teeth, and torestore a patient'schewing function. Thismay be accomplishedusing a single or 2-stagestage surgicalprocedure. | Intended to beconnected to anendosseous dentalimplant to support theplacement of a dentalprosthesis. | Same asReference Device#1 |
| Indications forUse | The Esthetic AbutmentNobel Biocare N1 TCCis a pre-manufacturedcomponent directlyconnected to anendosseous dentalimplant and isindicated for use as anaid in single unitprostheticrehabilitation. | The NobelActiveimplants are endosseousimplants intended to besurgically placed in thebone of the upper orlower jaw arches toprovide support forprosthetic devices, suchas an artificial tooth, inorder to restore patientesthetics and chewingfunction. NobelActiveimplants are indicated forsingle or multiple unitrestorations in splinted ornon-splintedapplications. NobelActiveimplants may be placedimmediately and put intoimmediately functionprovided that initialstability requirementsdetailed in the manualare satisfied. | Universal abutments areindicated to support theplacement of single unit,screw-retained prostheticrestorations in themaxillae or mandible.The Universal abutmentconsists of two majorparts. Specifically, thetitanium base andmesostructurecomponents make up atwo-piece abutment.The system integratesmultiple components ofthe digital dentistryworkflow scan files fromIntra-Oral Scanners,CAD software, CAMsoftware, ceramicmaterial, milling machineand associated toolingand accessories. | Same |
| DescriptiveInformation | Subject DeviceEsthetic AbutmentsNobel Biocare N1 ™TCC | Primary PredicateDeviceNobelActive InternalConnection Implant -K071370(limited to EstheticAbutment ConicalConnection) | Reference Device #1N1™ TiUltra™ TCCImplant system (N1 ™system) - K211109(limited to UniversalAbutment NobelBiocare N1™ TCC) | Comparison |
| Technological Characteristics | ||||
| CompatibleImplantsPlatforms | Narrow Platform (NP)Regular Platform (RP) | Narrow Platform (NP)Regular Platform (RP)Wide Platform (WP) | Narrow Platform (NP)Regular Platform (RP) | Same |
| ConnectionInterface | Trioval ConicalConnection (TCC) | Conical Connection(CC) | Trioval ConicalConnection (TCC) | Same asReferenceDevice #1 |
| Ti-baseMaterial | Titanium VanadiumAlloy(ASTM F136 and ISO5832-3) | Titanium VanadiumAlloy(ASTM F136 and ISO5832-3) | Titanium VanadiumAlloy(ASTM F136 and ISO5832-3) | Same |
| Angulation | Straight (0° angulation)and Angulated (15°) | Straight (0° angulation)and Angulated (15°) | Straight (0° angulation) | Same as PrimaryPredicate Device |
| AbutmentDesign | 1-piece abutmentAbutment pre-manufacturedSingle-unit | 1-piece abutmentAbutment pre-manufacturedSingle and Multi-unit | 2-piece abutmentAbutment pre-manufacturedSingle-unit | Same as PrimaryPredicate Device |
| AbutmentFixation | Abutment fixation witha screw. | Abutment fixation with ascrew. | Abutment fixation with ascrew. | Same |
| EstheticAbutmentTotal Height(measured fromimplant level) | Straight/ Angulated:1.75mm margin height:8 mm total height (canbe modified tominimum 5.6 mm)3mm margin height:9.5mm total height(can be modified tominimum 7.1mm) | Straight/ Angulated:1.5mm marginheight, 7.975 mm totalheight3mm margin height,9.475mm total height | 1.5mm marginheight, 5.55 mm totalheight3mm marginheight, 7.05mm totalheight | SubstantialEquivalencedemonstratedby fatiguetesting. |
| Abutmentmodification | Yes | Yes | No | Same as PrimaryPredicate Device |
| AbutmentDiameter | NP/RP: 4.4 mm (outerdiameter of triovalprofile) | NP: 4.2 mm x 4.88 mm | 4.5 mm (outer diameterof trioval profile) | SubstantialEquivalencedemonstrated byfatigue testing. |
| DesignWorkflow | Traditional | Traditional | ScannerKavo LS3, 3shape Triosor other scanners withequal or higheraccuracy than 6.9 µmDesign software | Same as PrimaryPredicate Device |
| DescriptiveInformation | Subject DeviceEsthetic AbutmentsNobel Biocare N1 ™TCC | Primary PredicateDeviceNobelActive InternalConnection Implant -K071370(limited to EstheticAbutment ConicalConnection) | Reference Device #1N1™ TiUltra™ TCCImplant system (N1 ™system) - K211109(limited to UniversalAbutment NobelBiocare N1 ™ TCC) | Comparison |
| DTX Studio Lab (theimplant libraries areautomatically included inthe software installer) or3Shape Dental Designer(the Implant Libraries areobtained via the 3Shapeserver in the software). | ||||
| ManufacturingWorkflow | N/A | N/A | Milling unit- Indicated for Zirconiamilling- Minimum5 axis millingtechnology- Minimum 30.000 rpmspindle speed | Same as PrimaryPredicate Device |
| SurfaceTreatment | Anodization | Anodization | Anodization | Same |
| SurfaceTopography | Ra 0.8 (TCCConnection Sa<0.6) | Ra 0.8 | Ra 1.6 (TCCConnection Sa<0.6) | Abutment -Same as Sameas PrimaryPredicateDeviceTCC Connection- Same asReferenceDevice #1 |
| SurfacePreservation | None | None | None | Same |
| Performance Testing | ||||
| Fatigue Testing | Fatigue testingaccording to ISO14801 | Fatigue testing accordingto ISO 14801 | Fatigue testing accordingto ISO 14801 | Same |
| MRI Testing | MR Conditional | MR Conditional(as per K212125) | MR Conditional(as per K212125) | Same asReference Device#2 |
| Biocompat-ibility | Biocompatibleaccording toISO 10993-1:2018 | Biocompatible accordingtoISO 10993-1:2018 | Biocompatible accordingtoISO 10993-1:2018 | Same |
Table 5-5: Esthetic Abutment Nobel Biocare N1™ TCC comparison table
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Image /page/12/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a stylized red letter N on the left, followed by the words "Nobel Biocare" in black text on the right. The word "Nobel" is on the top line, and the word "Biocare" is on the bottom line with a trademark symbol.
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Image /page/13/Picture/0 description: The image contains the logo for Nobel Biocare. On the left is a red stylized letter N. To the right of the N is the text "Nobel Biocare" stacked on two lines. The TM symbol is in superscript next to Biocare.
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Image /page/14/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a stylized red letter N on the left, followed by the words "Nobel Biocare" in black text on the right. The word "Biocare" has a trademark symbol next to it.
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Image /page/15/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 word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".
x.Substantial Equivalence - Device Line: Esthetic Abutment Nobel Biocare N1 ™ Base.
Details of the Similarities between the Subject and Predicate Device #2
The similarities between the Subject device line Esthetic Abutment Nobel Biocare N1 ™ Base and Predicate Device #2 as described in Table 5-6 are as follows:
- The Intended Use/Principle of Operation of the Subject Device and the Predicate . Device #2 are the same, with the only differences being the choice of similar wording. Both devices are used for supporting tooth replacements to restore chewing function. Furthermore, the Subject Device has the same Intended Use/Principle of operation as Reference Device #1.
- . The Indications for Use of the Subject device and the Predicate Device #2 is the same and expressed through a similar choice of words. Both devices are premanufactured prosthetic components that are connected to a Base level dental implant that are in turn connected to an endosseous dental implant.
- The macro design and characteristics of the Subject device and the Predicate ● Device #2 are identical. Both devices are 2-piece screw retained abutment devices made from titanium vanadium alloy (Ti6Al4V ELI according to ASTM F136 and ISO 5832-3 with an anodization surface treatment and the same surface topography.
- Both, the Subject Device, and the Predicate Device #2 are manufactured at the . same Nobel Biocare centralized manufacturing facility utilizing the same manufacturing technology.
- Both, the Subject Device, and the Predicate Device #2 support both Narrow (NP) ● and Regular Platform (RP).
- Both, the Subject Device, and the Predicate Device #2 are labelled MR Conditional. . The Reference Device #2 (Nobel Biocare Dental Implant Systems Portfolio - MR Conditional (K212125)) is included for reference to all MRI compatibility.
- The approach for non-clinical performance testing is the same for the Subject Device, and Predicate Device #2 with the same fatigue limits for the two platforms. Testing was furthermore conducted to confirm that the technological differences between the devices do not raise different questions of substantial equivalence. The results of these tests support the Subject Device met the performance specifications and performed as intended.
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Image /page/16/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red square with a stylized white "N" inside of it. To the right of the square is the text "Nobel Biocare" in black font, with "Nobel" on top of "Biocare" and a trademark symbol next to "Biocare".
Details of the differences between Subject and Predicate Device #2:
There are no major differences however there are minor differences between the subject device and the Predicate Device #2/References Device #1 such as:
- . Both the Subject and Predicate Device #2 connect directly to a base-level implant, which in turn connect to an endosseous dental implant. However, the base-level implant is specific to the implant system. This difference does not raise different questions of substantial equivalence. Fatigue testing was performed on the Subject Device and demonstrated comparable fatique performance. Furthermore, the same connection (N1 Base, engaging), with the same dimensions has been used for the Subject Device and the Reference Device #1.
- The device dimensions are different in the Subject Device and Predicate Device ● #2. However, the maximum and minimum device dimensions are within the range of the Predicate Device #2 and Reference Device #1. Dynamic fatigue test for endosseous dental implants to the FDA Guidance document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" was conducted in saline at 37 °C. The tests demonstrated the Subject Devices are substantially equivalent to the Predicate Device #2 and Reference Device #1.
Conclusion:
Based on a comparison of intended use, indications for use, technological characteristics, principle of operation, features, and performance data, the Esthetic Abutment Nobel Biocare N1™ Base is deemed to be substantially equivalent to the Predicate Device #2 as it satisfies all criteria of substantial equivalence and does not raise new concerns reqarding substantial equivalence: Indications for Use, Technological Characteristics and Performance Data. The new device does not introduce a fundamentally new scientific technoloqy and the nonclinical tests demonstrate that the device is substantial equivalent.
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Image /page/17/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red square with a stylized white "N" inside of it. To the right of the square is the text "Nobel Biocare" in black font, with "Nobel" on top of "Biocare".
Table 5-6: Esthetic Abutment Nobel Biocare N1™ Base comparison table
| DescriptiveInformation | Subject DeviceEsthetic AbutmentsNobel Biocare N1 ™Base | Predicate Device #2On1 Concept -K161655(limited to On1Esthetic AbutmentTitanium) | Reference Device#1N1™ TiUltra™ TCCImplant system(N1™ system) -K211109(limited toUniversalAbutment NobelBiocare N1 ™BaseTri) | Comparison |
|---|---|---|---|---|
| Manufacturer | Nobel Biocare AB | Nobel Biocare AB | Nobel Biocare AB | Same |
| PictorialRepresentation | Image: Esthetic Abutments Nobel Biocare N1 ™ Base | Image: On1 Concept - K161655 | Image: N1™ TiUltra™ TCC Implant system | N/A |
| Regulatory Classification | ||||
| Regulation # | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Same |
| Regulation Title | Endosseous dentalimplant abutment | Endosseous dentalimplant abutment | Endosseous dentalimplant abutment | Same |
| Regulation Class | II | II | II | Same |
| Product Code | NHA | NHA | NHA | Same |
| Indications for Use/Intended Use | ||||
| Intended Use | Intended to beconnected to anendosseous dentalimplant to supportthe placement of adental prosthesis. | The On1™ devicesare intended for usein the field ofdentistry. They areintended to be usedin the upper or lowerjaw for supportingtooth replacementsto restore chewingfunction andesthetics.The On1™abutments incombination with theOn1™ Baseon NobelBiocare ConicalConnectionendosseous implantsare indicated forsingle-unit screw and | Intended to beconnected to anendosseous dentalimplant to supportthe placement of adental prosthesis. | Similar to PredicateDevice #2Same as ReferenceDevice #1 |
| DescriptiveInformation | Subject DeviceEsthetic AbutmentsNobel Biocare N1™Base | Predicate Device #2On1 Concept -K161655(limited to On1Esthetic AbutmentTitanium) | Reference Device#1N1 ™ TiUltra™ TCCImplant system(N1™ system) -K211109(limited toUniversalAbutment NobelBiocare N1 ™BaseTri) | Comparison |
| cement retainedrestorations. | ||||
| Indications for Use | The EstheticAbutment NobelBiocare N1 Base is apre-manufacturedcomponentconnected to anendosseous dentalimplant and isindicated for use asan aid in single unitprostheticrehabilitation | The On1™ device isa pre-manufacturedprostheticcomponent directlyconnected to anendosseous implantand it is intended foruse in prostheticrehabilitation. | The UniversalAbutment NobelBiocare N1™ BaseTri is indicated tosupport theplacement of singleunit, screw-retainedprostheticrestorations in themaxilla or mandible. | Same |
| Technological Characteristics | ||||
| CompatibleImplants Platforms | Narrow Platform(NP)Regular Platform(RP) | Narrow Platform(NP)Regular Platform(RP)Wide Platform (WP) | Narrow Platform(NP)Regular Platform(RP) | Same |
| ConnectionInterface | N1 Base, engaging | On1, engaging | N1 Base, engaging | Same |
| Ti-base Material | MTA 005 Ti6Al4VELI (ISO 5832) | MTA 005 Ti6Al4VELI (ISO 5832) | MTA 005 Ti6Al4VELI (ISO 5832) | Same |
| Angulation | Straight (0°angulation) | Straight (0°angulation) | Straight (0°angulation) | Same as PrimaryPredicate DeviceSame as ReferenceDevice #1 |
| Abutment Design | 2-piece (baseplaced either at timeof implantplacement or withfinal abutment) | 2-piece (base placedeither at time ofimplant placement orwith final abutment)Abutment shapefixed | 3-piece abutment,pre-manufactured,Single-unit | Same as PredicateDevice #2 |
| Abutment Fixation | Abutment fixationwith a screw | Abutment fixationwith a screw | Abutment fixationwith a screw | Same |
| DescriptiveInformation | Subject DeviceEsthetic AbutmentsNobel Biocare N1 ™Base | Predicate Device #2On1 Concept -K161655(limited to On1Esthetic AbutmentTitanium) | Reference Device#1N1™ TiUltra™ TCCImplant system(N1™ system) -K211109(limited toUniversalAbutment NobelBiocare N1 ™BaseTri) | Comparison |
| MaximumAbutmentAngulation | Straight | Straight | Straight | Same |
| Total height(measured fromBase level) | 6.45 mm (can bemodified to 4.5 mm) | Total height On1Esthetic Abutment6.45mm | 4.5 mm | SubstantialEquivalencedemonstrated byfatigue testing |
| Abutmentmodification | Yes | Yes | No | Same as PredicateDevice #2 |
| Margin height | 0.5 mm | 0.3 mm | 0.45 mm | SubstantialEquivalencedemonstrated byfatigue testing |
| Abutment Diameter | NP: 4.6 mmRP: 4.8 mm | NP: 4.775 mmRP: 5.3 mm | NP: 4.8 mmRP: 5 mm | SubstantialEquivalencedemonstrated byfatigue testing |
| Design Workflow | Traditional | Traditional | · Scanner: KavoLS3, 3Shape Triosor other scannerswith equal or higheraccuracy than 6.9um.· Design software:DTX Studio Design(K181932,where the implantlibraries areautomaticallyincluded in thesoftware installer) or3Shape AbutmentDesigner Software(K151455, wherethe implantlibraries areobtained via the3Shape server in thesoftware). | Same as PredicateDevice #2 |
| DescriptiveInformation | Subject DeviceEsthetic AbutmentsNobel Biocare N1TMBase | Predicate Device #2On1 Concept -K161655(limited to On1Esthetic AbutmentTitanium) | Reference Device#1N1TM TiUltraTM TCCImplant system(N1TM system) -K211109(limited toUniversalAbutment NobelBiocare N1TMBaseTri) | Comparison |
| ManufacturingWorkflow | N/A | N/A | Milling unit- Indicated forZirconia milling- Minimum 5 axismillingtechnology- Minimum30.000rpm spindlespeed | Same as PredicateDevice #2 |
| Surface Treatment | Anodization | Anodization | Anodization | Same |
| SurfaceTopography | Ra 0.8 $ \mu $ m (N1 BaseConnection Ra=1.6$ \mu $ m) | Ra 0.8 $ \mu $ m (On1 BaseConnection RA=1.6$ \mu $ m) | Ra 0.8 $ \mu $ m (N1 BaseConnectionRa=1.6 $ \mu $ m) | Same |
| Performance Testing | ||||
| Fatigue Testing | Fatigue testingaccording to ISO14801 | Fatigue testingaccording to ISO14801 | Fatigue testingaccording to ISO14801 | Same |
| MRI Testing | MR Conditional | MR Conditional(as per K212125) | MR Conditional(as per K212125) | Same as ReferenceDevice #2 |
| Biocompatibility | Biocompatibleaccording toISO 10993-1:2018 | Biocompatibleaccording toISO 10993-1:2018 | Biocompatibleaccording toISO 10993-1:2018 | Same |
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Image /page/18/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 Biocare" in black text on the right. The word "Nobel" is on the top line, and the word "Biocare" is on the bottom line with a trademark symbol.
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Image /page/19/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 Biocare" in black text on the right. The "TM" symbol is present as a superscript next to the word Biocare.
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Image /page/20/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red square with a stylized white "N" inside of it. To the right of the square is the text "Nobel Biocare" in black font, with "Nobel" on the top line and "Biocare" on the bottom line.
xi. Performance Testing Data
Non-clinical testing was performed on the Subject device lines Esthetic Abutment Nobel Biocare N1™ TCC and Esthetic Abutment Nobel Biocare N1™ Base
- . 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).
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Image /page/21/Picture/0 description: The image contains the logo for Nobel Biocare. On the left side of the logo is a red symbol that resembles the letter N. To the right of the symbol is the text "Nobel Biocare" stacked on top of each other. The word "Biocare" has a trademark symbol next to it.
- 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,
Clinical Performance Data:
Clinical performance data is not required to establish substantial equivalence for the subject device.
xii. Conclusion
Based on a comparison of intended use, indications, material composition, technological characteristics, principle of operation, features and performance data, the Esthetic Abutments Nobel Biocare N1™ is deemed to be substantially equivalent to the Predicate Devices.
§ 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.)