(221 days)
No
The description focuses on the physical components and materials of a dental abutment, with no mention of AI or ML capabilities. The performance studies are non-clinical and relate to mechanical and material properties.
No
This device is a dental implant abutment used for prosthetic rehabilitation to restore esthetics and chewing function, which is not considered a therapeutic device in the sense of actively treating or curing a disease.
No.
The device is described as a pre-manufactured component directly connected to an endosseous dental implant, indicated for use as an aid in single unit prosthetic rehabilitation to restore patient esthetics and chewing function. There is no mention of diagnostic capabilities, assessment of health conditions, or detection of diseases.
No
The device description explicitly states the device is a "pre-manufactured dental implant abutment" made from "titanium vanadium alloy," indicating it is a physical hardware component, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the Esthetic Abutments Nobel Biocare N1™ are "pre-manufactured dental implant abutments" that are "directly connected to an endosseous dental implant." They are used to "restore patient esthetics and chewing function."
- Intended Use: The intended use is as an "aid in single unit prosthetic rehabilitation," which is a mechanical and structural function within the body, not an analysis of bodily specimens.
The device is a physical component implanted in the body for structural and functional restoration, not for diagnostic testing of biological samples.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
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.
Esthetic Abutments Nobel Biocare N1 ™ is composed of two device lines.
- Esthetic Abutment Nobel Biocare N1™ TCC
- Esthetic Abutment Nobel Biocare N1™ Base
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and/or lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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).
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
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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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
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 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:
Telephone Number:
Prepared By:
Date Prepared | Bernice Jim, Ph.D
regulatory.affairs@nobelbiocare.com
+41 79 855 00 73
Heather Yates
14 September 2022 | |
| ii. Device Name | | |
| Proprietary name:
Manufacturer:
Common Name:
Classification Name:
Regulation Number: | Esthetic Abutments Nobel Biocare N1TM
Nobel Biocare AB
Dental Abutment
Endosseous Dental Implant Abutment
21 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 – MR
Conditional (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 Nobel | ||||
| Biocare N1TM | TCC | straight (0°), 15° | NP, RP | 1.75 mm, 3mm |
| Esthetic Abutment Nobel | ||||
| Biocare 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".
| Article
No. | 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 |
| 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 NP
3.5x9mm | DZE | 872.3640 | K211109 |
| 300858 | Nobel Biocare N1™ TiUltra™ TCC NP
3.5x11mm | DZE | 872.3640 | K211109 |
| 300859 | Nobel Biocare N1™ TiUltra™ TCC NP
3.5x13mm | DZE | 872.3640 | K211109 |
| 300860 | Nobel Biocare N1™ TiUltra™ TCC RP
4.0x7mm | DZE | 872.3640 | K211109 |
| 300861 | Nobel Biocare N1™ TiUltra™ TCC RP
4.0x9mm | DZE | 872.3640 | K211109 |
| 300862 | Nobel Biocare N1™ TiUltra™ TCC RP
4.0x11mm | DZE | 872.3640 | K211109 |
| 300863 | Nobel Biocare N1™ TiUltra™ TCC RP
4.0x13mm | 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 NP
1.75mm | NHA | 872.3630 | K211109 |
| 300983 | Nobel Biocare N1™ Base Xeal™ TCC Tri NP
2.5mm | NHA | 872.3630 | K211109 |
| 300984 | Nobel Biocare N1™ Base Xeal™ TCC Tri NP
3.5mm | NHA | 872.3630 | K211109 |
| 300985 | Nobel Biocare N1™ Base Xeal™ TCC Tri RP
1.75mm | NHA | 872.3630 | K211109 |
| 300986 | Nobel Biocare N1™ Base Xeal™ TCC Tri RP
2.5mm | NHA | 872.3630 | K211109 |
| 300987 | Nobel Biocare N1™ Base Xeal™ TCC Tri RP
3.5mm | 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.
11
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.
| Descriptive
Information | Subject Device
Esthetic Abutments
Nobel Biocare N1 ™
TCC | Primary Predicate
Device
NobelActive Internal
Connection Implant –
K071370
(limited to Esthetic
Abutment Conical
Connection) | Reference Device #1
N1 ™ TiUltra™ TCC
Implant system (N1 ™
system) - K211109
(limited to Universal
Abutment Nobel
Biocare N1 ™ TCC) | Comparison |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Nobel Biocare AB | Nobel Biocare AB | Nobel Biocare AB | Same |
| Pictorial
Representation | Image: Esthetic Abutments Nobel Biocare N1 TCC | Image: NobelActive Internal Connection Implant | Image: N1 TiUltra TCC Implant system | N/A |
| Regulatory Classification | | | | |
| Descriptive
Information | Subject Device
Esthetic Abutments
Nobel Biocare N1 ™
TCC | Primary Predicate
Device
NobelActive Internal
Connection Implant -
K071370
(limited to Esthetic
Abutment Conical
Connection) | Reference Device #1
N1™ TiUltra™ TCC
Implant system (N1 ™
system) - K211109
(limited to Universal
Abutment Nobel
Biocare N1™ TCC) | Comparison |
| Regulation # | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Same |
| Regulation Title | Endosseous dental
implant abutment | Endosseous dental
implant abutment | Endosseous dental
implant abutment | Same |
| Regulation Class | II | II | II | Same |
| Product Code | NHA | NHA | NHA | Same |
| Indications for Use/Intended Use | | | | |
| Intended Use | Intended to be
connected to an
endosseous dental
implant to support the
placement of a dental
prosthesis. | The NobelActive
Endosseous Dental
Implants are intended to
be placed in the upper or
lower jaw to support
prosthetic devices such
as artificial teeth, and to
restore a patient's
chewing function. This
may be accomplished
using a single or 2-stage
stage surgical
procedure. | Intended to be
connected to an
endosseous dental
implant to support the
placement of a dental
prosthesis. | Same as
Reference Device
#1 |
| Indications for
Use | 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. | The NobelActive
implants are endosseous
implants intended to be
surgically placed in the
bone of the upper or
lower jaw arches to
provide support for
prosthetic devices, such
as an artificial tooth, in
order to restore patient
esthetics and chewing
function. NobelActive
implants are indicated for
single or multiple unit
restorations in splinted or
non-splinted
applications. NobelActive
implants may be placed
immediately and put into
immediately function
provided that initial
stability requirements
detailed in the manual
are satisfied. | Universal abutments are
indicated to support the
placement of single unit,
screw-retained prosthetic
restorations in the
maxillae or mandible.
The Universal abutment
consists of two major
parts. Specifically, the
titanium base and
mesostructure
components make up a
two-piece abutment.
The system integrates
multiple components of
the digital dentistry
workflow scan files from
Intra-Oral Scanners,
CAD software, CAM
software, ceramic
material, milling machine
and associated tooling
and accessories. | Same |
| Descriptive
Information | Subject Device
Esthetic Abutments
Nobel Biocare N1 ™
TCC | Primary Predicate
Device
NobelActive Internal
Connection Implant -
K071370
(limited to Esthetic
Abutment Conical
Connection) | Reference Device #1
N1™ TiUltra™ TCC
Implant system (N1 ™
system) - K211109
(limited to Universal
Abutment Nobel
Biocare N1™ TCC) | Comparison |
| | | Technological Characteristics | | |
| Compatible
Implants
Platforms | Narrow Platform (NP)
Regular Platform (RP) | Narrow Platform (NP)
Regular Platform (RP)
Wide Platform (WP) | Narrow Platform (NP)
Regular Platform (RP) | Same |
| Connection
Interface | Trioval Conical
Connection (TCC) | Conical Connection
(CC) | Trioval Conical
Connection (TCC) | Same as
Reference
Device #1 |
| Ti-base
Material | Titanium Vanadium
Alloy
(ASTM F136 and ISO
5832-3) | Titanium Vanadium
Alloy
(ASTM F136 and ISO
5832-3) | Titanium Vanadium
Alloy
(ASTM F136 and ISO
5832-3) | Same |
| Angulation | Straight (0° angulation)
and Angulated (15°) | Straight (0° angulation)
and Angulated (15°) | Straight (0° angulation) | Same as Primary
Predicate Device |
| Abutment
Design | 1-piece abutment
Abutment pre-
manufactured
Single-unit | 1-piece abutment
Abutment pre-
manufactured
Single and Multi-unit | 2-piece abutment
Abutment pre-
manufactured
Single-unit | Same as Primary
Predicate Device |
| Abutment
Fixation | Abutment fixation with
a screw. | Abutment fixation with a
screw. | Abutment fixation with a
screw. | Same |
| Esthetic
Abutment
Total Height
(measured from
implant level) | Straight/ Angulated:
1.75mm margin height:
8 mm total height (can
be modified to
minimum 5.6 mm)
3mm margin height:
9.5mm total height
(can be modified to
minimum 7.1mm) | Straight/ Angulated:
1.5mm margin
height, 7.975 mm total
height
3mm margin height,
9.475mm total height | 1.5mm margin
height, 5.55 mm total
height
3mm margin
height, 7.05mm total
height | Substantial
Equivalence
demonstrated
by fatigue
testing. |
| Abutment
modification | Yes | Yes | No | Same as Primary
Predicate Device |
| Abutment
Diameter | NP/RP: 4.4 mm (outer
diameter of trioval
profile) | NP: 4.2 mm x 4.88 mm | 4.5 mm (outer diameter
of trioval profile) | Substantial
Equivalence
demonstrated by
fatigue testing. |
| Design
Workflow | Traditional | Traditional | Scanner
Kavo LS3, 3shape Trios
or other scanners with
equal or higher
accuracy than 6.9 µm
Design software | Same as Primary
Predicate Device |
| Descriptive
Information | Subject Device
Esthetic Abutments
Nobel Biocare N1 ™
TCC | Primary Predicate
Device
NobelActive Internal
Connection Implant -
K071370
(limited to Esthetic
Abutment Conical
Connection) | Reference Device #1
N1™ TiUltra™ TCC
Implant system (N1 ™
system) - K211109
(limited to Universal
Abutment Nobel
Biocare N1 ™ TCC) | Comparison |
| | | | DTX Studio Lab (the
implant libraries are
automatically included in
the software installer) or
3Shape Dental Designer
(the Implant Libraries are
obtained via the 3Shape
server in the software). | |
| Manufacturing
Workflow | N/A | N/A | Milling unit
- Indicated for Zirconia
milling - Minimum5 axis milling
technology - Minimum 30.000 rpm
spindle speed | Same as Primary
Predicate Device |
| Surface
Treatment | Anodization | Anodization | Anodization | Same |
| Surface
Topography | Ra 0.8 (TCC
Connection Sa