Esthetic Abutments Nobel Biocare N1

K220339 · Nobel Biocare Services AG · NHA · Sep 16, 2022 · Dental

Device Facts

• Record ID: K220339
• Device Name: Esthetic Abutments Nobel Biocare N1
• Applicant: Nobel Biocare Services AG
• Product Code: NHA · Dental
• Decision Date: Sep 16, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Esthetic Abutments Nobel Biocare N1™ are pre-manufactured titanium-6 aluminum-4 vanadium alloy dental implant abutments. The TCC line connects directly to Nobel Biocare N1™ TCC implants via a tri-oval conical connection secured by a clinical screw. The Base line connects to a Nobel Biocare N1™ Base Xeal™ component via a prosthetic screw, which then connects to the implant. Used in dental clinics by clinicians to restore chewing function and esthetics in edentulous patients. Abutments can be modified in a dental laboratory. Output is a stable prosthetic foundation for a dental crown. Benefits include restoration of oral function and esthetics. Device is MR Conditional.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including dynamic fatigue testing per ISO 14801 and FDA guidance, MRI compatibility testing (ASTM F2052, F2213, F2119, F2182), biocompatibility (ISO 10993-1), and sterilization validation (ISO 17665-1, AAMI TIR12).

Technological Characteristics

Materials: Titanium-6 Aluminum-4 Vanadium alloy (ASTM F136, ISO 5832-3) with anodization. Connection: Tri-oval conical (TCC) or engaging base. Platforms: NP, RP. Dimensions: Various heights/diameters. Sterilization: Validated per ISO 17665-1. MR Conditional. Traditional workflow.

Indications for Use

Indicated for single unit prosthetic rehabilitation in partially or fully edentulous patients requiring restoration of esthetics and chewing function via connection to an endosseous dental implant in the upper or lower jaw.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

• NobelActive Internal Connection Implant (K071370)
• On1 Concept (K161655)

Reference Devices

• N1™ TiUltra™ TCC Implant system (N1™ system) (K211109)
• Nobel Biocare Dental Implant Systems Portfolio – MR Conditional (K212125)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

K220339

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<br>Vastra Hamngatan 1<br>Goteborg 411 17<br>Sweden | |
|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitted By: | Nobel Biocare Services AG<br>Balz-Zimmerman-Strasse 7<br>8302 Kloten<br>Switzerland | |
| Contact Person:<br>E-Mail:<br>Telephone Number:<br>Prepared By:<br>Date Prepared | Bernice Jim, Ph.D<br>[e-mail]<br>[phone]<br>Heather Yates<br>14 September 2022 | |
| ii. Device Name | | |
| Proprietary name:<br>Manufacturer:<br>Common Name:<br>Classification Name:<br>Regulation Number: | Esthetic Abutments Nobel Biocare N1TM<br>Nobel Biocare AB<br>Dental Abutment<br>Endosseous Dental Implant Abutment<br>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<br>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<br>Biocare N1TM | TCC | straight (0°), 15° | NP, RP | 1.75 mm, 3mm |
| Esthetic Abutment Nobel<br>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<br>No. | Product Name | Product<br>Code | Regulation<br># | 510(k)<br>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<br>3.5x9mm | DZE | 872.3640 | K211109 |
| 300858 | Nobel Biocare N1™ TiUltra™ TCC NP<br>3.5x11mm | DZE | 872.3640 | K211109 |
| 300859 | Nobel Biocare N1™ TiUltra™ TCC NP<br>3.5x13mm | DZE | 872.3640 | K211109 |
| 300860 | Nobel Biocare N1™ TiUltra™ TCC RP<br>4.0x7mm | DZE | 872.3640 | K211109 |
| 300861 | Nobel Biocare N1™ TiUltra™ TCC RP<br>4.0x9mm | DZE | 872.3640 | K211109 |
| 300862 | Nobel Biocare N1™ TiUltra™ TCC RP<br>4.0x11mm | DZE | 872.3640 | K211109 |
| 300863 | Nobel Biocare N1™ TiUltra™ TCC RP<br>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<br>1.75mm | NHA | 872.3630 | K211109 |
| 300983 | Nobel Biocare N1™ Base Xeal™ TCC Tri NP<br>2.5mm | NHA | 872.3630 | K211109 |
| 300984 | Nobel Biocare N1™ Base Xeal™ TCC Tri NP<br>3.5mm | NHA | 872.3630 | K211109 |
| 300985 | Nobel Biocare N1™ Base Xeal™ TCC Tri RP<br>1.75mm | NHA | 872.3630 | K211109 |
| 300986 | Nobel Biocare N1™ Base Xeal™ TCC Tri RP<br>2.5mm | NHA | 872.3630 | K211109 |
| 300987 | Nobel Biocare N1™ Base Xeal™ TCC Tri RP<br>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.

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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.

| Descriptive<br>Information | Subject Device<br>Esthetic Abutments<br>Nobel Biocare N1 ™<br>TCC | Primary Predicate<br>Device<br>NobelActive Internal<br>Connection Implant –<br>K071370<br>(limited to Esthetic<br>Abutment Conical<br>Connection) | Reference Device #1<br>N1 ™ TiUltra™ TCC<br>Implant system (N1 ™<br>system) - K211109<br>(limited to Universal<br>Abutment Nobel<br>Biocare N1 ™ TCC) | Comparison |
|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Nobel Biocare AB | Nobel Biocare AB | Nobel Biocare AB | Same |
| Pictorial<br>Representation | Image: Esthetic Abutments Nobel Biocare N1 TCC | Image: NobelActive Internal Connection Implant | Image: N1 TiUltra TCC Implant system | N/A |
| Regulatory Classification | | | | |
| Descriptive<br>Information | Subject Device<br>Esthetic Abutments<br>Nobel Biocare N1 ™<br>TCC | Primary Predicate<br>Device<br>NobelActive Internal<br>Connection Implant -<br>K071370<br>(limited to Esthetic<br>Abutment Conical<br>Connection) | Reference Device #1<br>N1™ TiUltra™ TCC<br>Implant system (N1 ™<br>system) - K211109<br>(limited to Universal<br>Abutment Nobel<br>Biocare N1™ TCC) | Comparison |
| Regulation # | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Same |
| Regulation Title | Endosseous dental<br>implant abutment | Endosseous dental<br>implant abutment | Endosseous dental<br>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<br>connected to an<br>endosseous dental<br>implant to support the<br>placement of a dental<br>prosthesis. | The NobelActive<br>Endosseous Dental<br>Implants are intended to<br>be placed in the upper or<br>lower jaw to support<br>prosthetic devices such<br>as artificial teeth, and to<br>restore a patient's<br>chewing function. This<br>may be accomplished<br>using a single or 2-stage<br>stage surgical<br>procedure. | Intended to be<br>connected to an<br>endosseous dental<br>implant to support the<br>placement of a dental<br>prosthesis. | Same as<br>Reference Device<br>#1 |
| Indications for<br>Use | The Esthetic Abutment<br>Nobel Biocare N1 TCC<br>is a pre-manufactured<br>component directly<br>connected to an<br>endosseous dental<br>implant and is<br>indicated for use as an<br>aid in single unit<br>prosthetic<br>rehabilitation. | The NobelActive<br>implants are endosseous<br>implants intended to be<br>surgically placed in the<br>bone of the upper or<br>lower jaw arches to<br>provide support for<br>prosthetic devices, such<br>as an artificial tooth, in<br>order to restore patient<br>esthetics and chewing<br>function. NobelActive<br>implants are indicated for<br>single or multiple unit<br>restorations in splinted or<br>non-splinted<br>applications. NobelActive<br>implants may be placed<br>immediately and put into<br>immediately function<br>provided that initial<br>stability requirements<br>detailed in the manual<br>are satisfied. | Universal abutments are<br>indicated to support the<br>placement of single unit,<br>screw-retained prosthetic<br>restorations in the<br>maxillae or mandible.<br>The Universal abutment<br>consists of two major<br>parts. Specifically, the<br>titanium base and<br>mesostructure<br>components make up a<br>two-piece abutment.<br>The system integrates<br>multiple components of<br>the digital dentistry<br>workflow scan files from<br>Intra-Oral Scanners,<br>CAD software, CAM<br>software, ceramic<br>material, milling machine<br>and associated tooling<br>and accessories. | Same |
| Descriptive<br>Information | Subject Device<br>Esthetic Abutments<br>Nobel Biocare N1 ™<br>TCC | Primary Predicate<br>Device<br>NobelActive Internal<br>Connection Implant -<br>K071370<br>(limited to Esthetic<br>Abutment Conical<br>Connection) | Reference Device #1<br>N1™ TiUltra™ TCC<br>Implant system (N1 ™<br>system) - K211109<br>(limited to Universal<br>Abutment Nobel<br>Biocare N1™ TCC) | Comparison |
| | | Technological Characteristics | | |
| Compatible<br>Implants<br>Platforms | Narrow Platform (NP)<br>Regular Platform (RP) | Narrow Platform (NP)<br>Regular Platform (RP)<br>Wide Platform (WP) | Narrow Platform (NP)<br>Regular Platform (RP) | Same |
| Connection<br>Interface | Trioval Conical<br>Connection (TCC) | Conical Connection<br>(CC) | Trioval Conical<br>Connection (TCC) | Same as<br>Reference<br>Device #1 |
| Ti-base<br>Material | Titanium Vanadium<br>Alloy<br>(ASTM F136 and ISO<br>5832-3) | Titanium Vanadium<br>Alloy<br>(ASTM F136 and ISO<br>5832-3) | Titanium Vanadium<br>Alloy<br>(ASTM F136 and ISO<br>5832-3) | Same |
| Angulation | Straight (0° angulation)<br>and Angulated (15°) | Straight (0° angulation)<br>and Angulated (15°) | Straight (0° angulation) | Same as Primary<br>Predicate Device |
| Abutment<br>Design | 1-piece abutment<br>Abutment pre-<br>manufactured<br>Single-unit | 1-piece abutment<br>Abutment pre-<br>manufactured<br>Single and Multi-unit | 2-piece abutment<br>Abutment pre-<br>manufactured<br>Single-unit | Same as Primary<br>Predicate Device |
| Abutment<br>Fixation | Abutment fixation with<br>a screw. | Abutment fixation with a<br>screw. | Abutment fixation with a<br>screw. | Same |
| Esthetic<br>Abutment<br>Total Height<br>(measured from<br>implant level) | Straight/ Angulated:<br>1.75mm margin height:<br>8 mm total height (can<br>be modified to<br>minimum 5.6 mm)<br>3mm margin height:<br>9.5mm total height<br>(can be modified to<br>minimum 7.1mm) | Straight/ Angulated:<br>1.5mm margin<br>height, 7.975 mm total<br>height<br>3mm margin height,<br>9.475mm total height | 1.5mm margin<br>height, 5.55 mm total<br>height<br>3mm margin<br>height, 7.05mm total<br>height | Substantial<br>Equivalence<br>demonstrated<br>by fatigue<br>testing. |
| Abutment<br>modification | Yes | Yes | No | Same as Primary<br>Predicate Device |
| Abutment<br>Diameter | NP/RP: 4.4 mm (outer<br>diameter of trioval<br>profile) | NP: 4.2 mm x 4.88 mm | 4.5 mm (outer diameter<br>of trioval profile) | Substantial<br>Equivalence<br>demonstrated by<br>fatigue testing. |
| Design<br>Workflow | Traditional | Traditional | Scanner<br>Kavo LS3, 3shape Trios<br>or other scanners with<br>equal or higher<br>accuracy than 6.9 µm<br>Design software | Same as Primary<br>Predicate Device |
| Descriptive<br>Information | Subject Device<br>Esthetic Abutments<br>Nobel Biocare N1 ™<br>TCC | Primary Predicate<br>Device<br>NobelActive Internal<br>Connection Implant -<br>K071370<br>(limited to Esthetic<br>Abutment Conical<br>Connection) | Reference Device #1<br>N1™ TiUltra™ TCC<br>Implant system (N1 ™<br>system) - K211109<br>(limited to Universal<br>Abutment Nobel<br>Biocare N1 ™ TCC) | Comparison |
| | | | DTX Studio Lab (the<br>implant libraries are<br>automatically included in<br>the software installer) or<br>3Shape Dental Designer<br>(the Implant Libraries are<br>obtained via the 3Shape<br>server in the software). | |
| Manufacturing<br>Workflow | N/A | N/A | Milling unit<br>- Indicated for Zirconia<br>milling<br>- Minimum5 axis milling<br>technology<br>- Minimum 30.000 rpm<br>spindle speed | Same as Primary<br>Predicate Device |
| Surface<br>Treatment | Anodization | Anodization | Anodization | Same |
| Surface<br>Topography | Ra 0.8 (TCC<br>Connection Sa<0.6) | Ra 0.8 | Ra 1.6 (TCC<br>Connection Sa<0.6) | Abutment -<br>Same as Same<br>as Primary<br>Predicate<br>Device<br>TCC Connection<br>- Same as<br>Reference<br>Device #1 |
| Surface<br>Preservation | None | None…