Titanium Abutment Blank Nobel Biocare N1 TCC

K223677 · Nobel Biocare AB · NHA · Apr 28, 2023 · Dental

Device Facts

• Record ID: K223677
• Device Name: Titanium Abutment Blank Nobel Biocare N1 TCC
• Applicant: Nobel Biocare AB
• Product Code: NHA · Dental
• Decision Date: Apr 28, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured prosthetic component directly connected to an endosseous dental implant and is indicated for use as an aid in prosthetic rehabilitation for single units and multiple units of up to three units. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

Device Story

Premanufactured titanium abutment blank; customized via CAD/CAM workflow in dental office or laboratory. Input: digital scan files from intra-oral scanners. Processing: CAD/CAM software designs patient-specific anatomy; milling machine fabricates custom shape from blank. Output: patient-specific abutment for dental restoration. Used by dental professionals; connects to N1™ TiUltra implants via mechanical screw; restoration attached via cement. Benefits: enables patient-specific prosthetic rehabilitation using digital dentistry workflow.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including biocompatibility (ISO 10993), fatigue testing (per FDA guidance), and software/workflow validation.

Technological Characteristics

Material: Ti6Al4V ELI (ISO 5832-3, ASTM F136). Connection: Mechanical screw-retained to implant, cement-retained to restoration. Form factor: Premanufactured blank with non-patient-specific implant interface. Sterilization: Non-sterile, user-sterilized. Connectivity: Digital workflow integration (scanners, CAD/CAM).

Indications for Use

Indicated for prosthetic rehabilitation of single or multiple units (up to three) in patients requiring dental implant-supported restorations. Used in conjunction with endosseous dental implants.

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

• Elos Accurate® Customized Abutment (K222044)

Reference Devices

• DESS Dental Smart Solutions (K222288)
• NobelProcera Ti Abutment Camlog Platforms (K122602)
• Nobel Biocare Dental Implant Systems Portfolio - MR Conditional (K212125)
• Esthetic Abutments Nobel Biocare N1™ (K220339)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Nobel Biocare AB Bernice Jim Head of RA Product Development and Marketed Products Vastra Hamngatan 1 Goteborg, Vastra Gotaland SE 411 17 SWEDEN

Re: K223677

Trade/Device Name: Titanium Abutment Blank Nobel Biocare N1™ TCC Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: March 29, 2023 Received: March 29, 2023

Dear Bernice Jim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K223677

Device Name

Titanium Abutment Blank Nobel Biocare N1TM TCC

Indications for Use (Describe)

Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured prosthetic component directly connected to an endosseous dental implant and is indicated for use as an aid in prosthetic rehabilitation for single units of up to three units. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------|---------------------------------------------|
|----------------------------------------------|---------------------------------------------|

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Image /page/3/Picture/0 description: The image shows the logo for Nobel Biocare. On the left is a red square with a white "N" inside. To the right of the square is the text "Nobel Biocare" in black. The word "Nobel" is on the top line and "Biocare" is on the bottom line with a trademark symbol.

# 510(k) Summary K223677

# For Titanium Abutment Blank Nobel Biocare N1™ TCC

#### 1. Submitter Information

Submitter:

Nobel Biocare AB P.O. Box 5190, 402 26 Västra Hamngatan 1 Goteborg, SE-411 17 Sweden

Bernice Jim, PhD

[phone]

27 April 2023

Submitted By:

Nobel Biocare Services AG Balz Zimmermann-Str. 7 8302 Kloten Switzerland

[e-mail]

Nicole Fuchs/Corinne Larke-Grass

| Contact Person: |
|-------------------|
| E-Mail: |
| Telephone number: |
| Prepared by: |
| Date Prepared: |

## 2. Device Name

Proprietary Name: Titanium Abutment Blank Nobel Biocare N1™ TCC Manufacturer: Nobel Biocare AB Generic/Common Name: Abutment, Implant, Dental, Endosseous Requlation Name: Endosseous Dental Implant Abutment Regulation Number: 21 CFR§872.3630 Regulatory Class: ll Primary Product Code: NHA Secondary Product Code: PNP

### 3. Predicate Device

Predicate Device Proprietary Name: Manufacturer: Generic/Common Name: Regulation Name: Regulation Number: Regulatory Class: ll Primary Product Code: Secondary Product Code: Clearance:

Reference Device #1 Proprietary Name: Manufacturer:

Elos Accurate® Customized Abutment Elos Medtech Pinol A/S Abutment, Implant, Dental, Endosseous Endosseous Dental Implant Abutment 21 CFR§872.3630 NHA PNP K222044

DESS Dental Smart Solutions Terrats Medical SL

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Image /page/4/Picture/0 description: The image contains the logo for Nobel Biocare. On the left is a red symbol that looks like a stylized letter N. To the right of the symbol is the text "Nobel Biocare" in a simple, sans-serif font. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".

| Generic/Common Name: | Abutment, Implant, Dental, Endosseous |
|-----------------------|-----------------------------------------------------------------|
| Regulation Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR§872.3630 |
| Regulatory Class: | II |
| Primary Product Code: | NHA |
| Clearance: | K222288 |
| Reference Device #2 | |
| Proprietary Name: | NobelProcera Ti Abutment Camlog Platforms |
| Manufacturer: | Nobel Biocare AB |
| Generic/Common Name: | Abutment, Implant, Dental, Endosseous |
| Regulation Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR§872.3630 |
| Regulatory Class: | II |
| Product Code: | NHA |
| Clearance: | K122602 |
| Reference Device #3 | |
| Proprietary Name: | Nobel Biocare Dental Implant Systems Portfolio - MR Conditional |
| Manufacturer: | Nobel Biocare AB |
| Generic/Common Name: | Implant, Dental, Endosseous |
| Regulation Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3640, 21 CFR 872.3630, 21 CFR 872.4120 |
| Regulatory Class: | II |
| Product Code: | DZE, NHA, PNP, DZI |
| Clearance: | K212125 |
| Reference Device #4 | |
| Proprietary Name: | Esthetic Abutments Nobel Biocare N1 ™ |
| Manufacturer: | Nobel Biocare AB |
| Generic/Common Name: | Abutment, Dental, Endosseous |
| Regulation Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR§872.3630 |
| Regulatory Class: | II |
| Product Code: | NHA |
| Clearance: | K220339 |

# 4. Device Description

The Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured titanium abutment which can be customized via a validated CAD/CAM workflow in the dental office or dental laboratory to meet patient-specific anatomical requirements. The customization of the subject device is designed using a dental laboratory software and milled in the dental laboratory, using a Computer Aided Design (CAD)/Computer Aided Manufacturing (CAM) machine.

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Image /page/5/Picture/0 description: The image shows the logo for Nobel Biocare. The logo consists of a red letter N on the left and the words "Nobel Biocare" on the right. The letter N is stylized and made up of two intersecting lines. The word "Nobel" is above the word "Biocare", and there is a trademark symbol after the word "Biocare".

All digitally designed CAD/CAM customizations for the Titanium Abutment Blank Nobel Biocare N1™ TCC are only intended to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

The subject device has a premanufactured connection for the Nobel Biocare N1 ™ TCC TiUltra implants on one end and a premanufactured connection for the milling blank holder on the other end. These connections are not patient-specific.

The subject device is available for NP and RP implant platforms.

The subject device is used by dental healthcare professionals in dental offices and dental laboratories.

The subject device is composed of titanium vanadium alloy Ti6Al4V ELI (ISO 5832-3, ASTM F136) and features a surface with the same anodization already cleared in K211109.

It is an implantable single use device. The device is provided non-sterile and intended to be sterilized by the user prior to placement in the patient.

The Titanium Abutment Blank Nobel Biocare N1™ TCC is packaged with a Clinical Screw NB N1 TCC.

| Subject Device | 301511 – Ti Abutment<br>Blank NB N1 TCC NP<br>Ø10 mm | 301512 – Ti Abutment<br>Blank NB N1 TCC RP<br>Ø10 mm |
|-------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|
| Maximum abutment angulation | | 30° |
| Minimum screw channel thickness (min. wall thickness) | 0.38mm | 0.49mm |
| Maximum abutment height from implant level | | 16mm |
| Minimum diameter | 3.21mm | 3.49mm |
| Maximum diameter | | 9.95mm |
| Minimum post height | | 4.05mm |
| Maximum post height | | 15.665mm |
| Minimum gingival margin height | | 0.335mm |
| Maximum margin height | | 4.6mm |

#### Table 1: Design Parameters

### Principle of Operation / Mechanism of Action

The customized subject device acts as connecting element between a dental implant and a restoration. The mechanism of action is a mechanical screw connection, through the use of a clinical screw, and through a cemented connection to a restoration.

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Image /page/6/Picture/0 description: The image contains the logo for Nobel Biocare. On the left side of the logo is a red symbol that looks like the letter N. To the right of the symbol is the company name, Nobel Biocare, in black font. The word Nobel is on the top line, and Biocare is on the second line with the trademark symbol.

#### Compatible Devices:

The Titanium Abutment Blanks Nobel Biocare N1™ TCC are compatible with N1™ TiUltra TCC implants.

## 5. Indications for Use

Titanium Abutment Blank Nobel Biocare N1™ TCC is a premanufactured prosthetic component directly connected to an endosseous dental implant and is indicated for use as an aid in prosthetic rehabilitation for single units and multiple units of up to three units.

The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, milling machine and associated tooling and accessories.

## 6. Description of Substantial Equivalence

Overall, the subject device has the following substantial equivalences to the predicate device: similar intended use, the same operating principle, incorporates a similar basic design, incorporates the same materials, customizes to fit patient specific anatomical requirements, same methods of sterility and requires a digital dentistry workflow to manufacture at point of care .

Both subject and predicate abutment devices are premanufactured prosthetic components directly connected to the endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation. Therefore, the devices are substantially equivalent in the consideration of intended use and Indications for Use.

The technological differences between the subject and the predicate device do not affect the shared intended use nor raise different questions of substantial equivalence, as demonstrated by non-clinical testing.

Table 2 below shows the substantial equivalence comparison for the subject device.

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Image /page/7/Picture/0 description: The image contains the logo for Nobel Biocare. The logo consists of a red square with a white "N" inside of it. To the right of the square is the text "Nobel Biocare™" in black font.

| Table 2: Titanium Abutment Blank Nobel Biocare N1™ TCC comparison table | |
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| Characteristic | Subject Device<br>Titanium Abutment Blank Nobel<br>Biocare N1 TCC | Predicate Device<br>Elos Accurate® Customized<br>Abutment | Reference Device #1<br>DESS Dental Smart Solutions | Reference Device #2<br>NobelProcera Ti Abutment<br>Camlog Platforms | Comparison |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| | K223677 | K222044 | K222288 | K122602 | |
| Product<br>Classification | Class II | Class II | Class II | Class II | Identical |
| Regulation Number<br>/ Name | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Identical |
| | Endosseous Dental Implant<br>Abutment | Endosseous Dental Implant<br>Abutment | Endosseous Dental Implant<br>Abutment | Endosseous Dental Implant<br>Abutment | Identical |
| Product Code,<br>primary | NHA | NHA | NHA | NHA | Identical |
| Product Code,<br>secondary | PNP | PNP | N/A | NHA | Identical |
| Review Panel | Dental | Dental | Dental | Dental | Identical |
| Intended Use | Intended to be connected to an<br>endosseous dental implant to<br>support the placement of a dental<br>prosthesis. | Support of a prosthesis to restore<br>chewing function. | -- | -- | Similar intended use<br>as the Primary<br>Predicate<br>expressed through<br>a similar choice of<br>words. |
| Characteristic | Subject Device | Predicate Device | Reference Device #1 | Reference Device #2 | Comparison |
| | Titanium Abutment Blank Nobel<br>Biocare N1 TCC | Elos Accurate® Customized<br>Abutment | DESS Dental Smart Solutions | NobelProcera Ti Abutment<br>Camlog Platforms | |
| | K223677 | K222044 | K222288 | K122602 | |
| Indications for Use | Titanium Abutment Blank Nobel<br>Biocare N1™ TCC is a<br>premanufactured prosthetic<br>component directly connected to<br>an endosseous dental implant and<br>is indicated for use as an aid in<br>prosthetic rehabilitation for single<br>units and multiple units of up to<br>three units<br>The system integrates multiple<br>components of the digital dentistry<br>workflow: scan files from Intra-Oral<br>Scanners, CAD software, CAM<br>software, milling machine and<br>associated tooling and accessories | The Elos Accurate® Customized<br>Abutments are intended for<br>attaching to dental implants in<br>order to<br>provide basis for single or multiple<br>tooth prosthetic restorations. The<br>Elos Accurate® Customized<br>Abutment will be attached to a<br>dental implant using the included<br>Elos Prosthetic screw.<br>The Elos Accurate® Customized<br>Abutments are compatible with the<br>implant systems listed in Table 1:<br>All digitally designed CAD/CAM<br>customizations for the Elos<br>Accurate® Customized Abutments<br>are only<br>intended to be designed and<br>manufactured according to digital<br>dentistry workflow. The workflow<br>system integrates multiple<br>components of the digital dentistry<br>workflow: scan files from Intra-Oral<br>Scanners, CAD software, CAM<br>software, milling machine and<br>associated tooling and<br>accessories. | DESS Dental Smart Solutions<br>abutments are intended to be used<br>in conjunction with endosseous<br>dental implants in the maxillary or<br>mandibular arch to provide support<br>for prosthetic restorations.<br>All digitally designed custom<br>abutments for use with Ti Base<br>abutments or Pre-milled Blank<br>abutments are to be sent to a<br>Terrats Medical validated milling<br>center for manufacture. | The NobelProcera Ti Abutments<br>Camlog Platforms are<br>premanufactured prosthetic<br>components directly connected to<br>endosseous dental implants and<br>are<br>intended for use as an aid in<br>prosthetic rehabilitation. They are<br>compatible with the Camlog K<br>series 3.3, 3.8, 4.3, 5.0 and 6.0<br>implants. | Similar Indications<br>for Use as the<br>Primary Predicate<br>expressed through<br>a similar choice of<br>words. |
| Minimum wall<br>thickness: | NP 0.38mm<br>RP 0.49mm | 0.4 - 0.5mm (Implant Platform<br>dependent) | 0.45mm | 0.3mm<br>-- | Similar as reference<br>device #2.<br>Substantial<br>equivalence, as<br>demonstrated by<br>fatigue testing. |
| Characteristic | Subject Device | Predicate Device | Reference Device #1 | Reference Device #2 | |
| | Titanium Abutment Blank Nobel<br>Biocare N1 TCC | Elos Accurate® Customized<br>Abutment | DESS Dental Smart Solutions | NobelProcera Ti Abutment<br>Camlog Platforms | Comparison |
| | K223677 | K222044 | K222288 | K122602 | |
| Minimum gingiva<br>height: | 0.335 mm | 0.5mm | 0.3mm | -- | Similar as reference<br>device #1.<br>Substantial<br>equivalence, as<br>demonstrated by<br>fatigue testing. |
| Minimum diameter | NP Ø3.21mm<br>RP Ø3.49mm | 3.0 - 6.0 mm (Implant Platform<br>dependent) | 2.52 - 6.0 mm (Implant Platform<br>dependent) | -- | Similar |
| Minimum post<br>height: | 4.05mm | 4mm | 4mm | -- | Similar |
| Abutment Shape | Patient specific | Patient specific | Patient specific | Patient Specific | Identical |
| Platform<br>compatibility | Narrow Platform (NP)<br>Regular Platform (RP) | Narrow Platform (NP)<br>Regular Platform (RP) | Narrow Platform (NP)<br>Regular Platform (RP) | 3.3, 3.8, 4.3, 5.0, 6.0 | Identical |
| Attachment<br>method to implant | Screw retained | Screw retained | Screw retained | Screw retained | Identical |
| Prosthesis<br>attachment method | Cement retained | Cement retained | Screw or cement retained | Cement retained | Identical |
| Restoration type | Single-unit and multi-unit (up to 3<br>units) | Single-unit and multi-unit | Single-unit and multi-unit | Single-unit | Similar |
| Design features | Pre-manufactured implant-<br>interface connection, customizable<br>cylindrical abutment body | Pre-manufactured implant-<br>interface connection, customizable<br>cylindrical abutment body | -- | Pre-manufactured implant-<…