NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium

K233208 · Nobel Biocare AB · NHA · Jan 24, 2024 · Dental

Device Facts

• Record ID: K233208
• Device Name: NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium
• Applicant: Nobel Biocare AB
• Product Code: NHA · Dental
• Decision Date: Jan 24, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NobelProcera® Abutment Titanium is a patient-matched CAD/CAM prosthetic component directly connected to endosseous dental implants and is indicated for use as an aid in prosthetic rehabilitation. Clinical and Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.

Device Story

Patient-matched CAD/CAM prosthetic components; includes NobelProcera Titanium ASC Abutment and Omnigrip Clinical Screw Titanium. Abutment connects to endosseous dental implants (internal conical or tri-channel connection) to support cement-retained dental prostheses. Features angulated screw channel (0°-30°). Clinical screw secures abutment/framework to implant. Used in dental clinics by clinicians. Input: patient-specific anatomical data for CAD/CAM design. Output: finished titanium abutment and screw. Benefits: restores chewing function and esthetics. MR Conditional.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing: packaging (ASTM D4169), dynamic loading (ISO 14801), MR compatibility (ASTM F2052, F2213, F2119, F2182), biocompatibility (ISO 10993-1), and cleaning/sterilization validation (ISO 17665-1).

Technological Characteristics

Materials: Ti6Al4V ELI (ISO 5832-3, ASTM F136). Connection: Internal conical or tri-channel. Features: Angulated screw channel (0°-30°), optional anodization, optional DLC coating. Dimensions: 4.4-16mm diameter, 4-14.7mm post height. Connectivity: N/A (mechanical). Sterilization: End-user validated. Software: CAD/CAM design workflow.

Indications for Use

Indicated for partially edentulous patients requiring prosthetic devices and/or endosseous implants to restore chewing function and esthetic appearance.

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

• NobelProcera® Abutment Titanium (K091756)
• Omnigrip Clinical Screw CC (K132746)

Reference Devices

• NobelProcera Angulated Screw Channel Abutment Conica Connection (K132746)
• DESS® Dental Smart Solutions (K221301)
• Universal Abutment NB N1 TCC (K211109)
• NOBELACTIVE WIDE PLATFORM (WP) (K133731)
• Titanium Abutment Blank Nobel Biocare N1 TM TCC (K223677)
• NOBELACTIVE MULTI UNIT ABUTMENT (K072570)
• Trefoil System (K170135)
• 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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 24, 2024

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

Re: K233208

Trade/Device Name: NobelProcera® Titanium ASC Abutment, Omnigrip Clinical Screw Titanium Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 28, 2023 Received: December 20, 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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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 -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 Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

Submission Number (if known)

K233208

Device Name

NobelProcera Titanium® ASC Abutments; Omnigrip Clinical Screw Titanium

Indications for Use (Describe)

NobelProcera® Titanium ASC Abutments:

NobelProcera® Abutment Titanium is a patient-matched CAD/CAM prosthetic component directly connected to endosseous dental implants and is indicated for use as an aid in prosthetic rehabilitation.

Omnigrip Clinical Screw Titanium:

Clinical and Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.

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/4/Picture/0 description: The image contains the logo for Nobel Biocare. The logo consists of a stylized red letter "N" enclosed in a square, followed by the words "Nobel Biocare" in black text. The word "Nobel" is placed above the word "Biocare", and there is a trademark symbol after the word "Biocare".

### 1 – 510(k) Summary – K233208

#### 1.1 Submitter Information

- Nobel Biocare AB Submitter: Vastra Hamngatan 1 Goteborg 411 17 Sweden
- Submitted By: Nobel Biocare Services AG Balz-Zimmerman-Strasse 7 8302 Kloten Switzerland

| Contact Person: | Bernice Jim, Ph.D |
|-------------------|-------------------------------------|
| E-Mail: | [e-mail] |
| Telephone Number: | [phone] |
| Prepared By: | Nicole Fuchs, MLaw |
| Date Prepared: | January 24th, 2024 |

### 1.2 Device Name No. 1

| Proprietary name: | NobelProcera® Titanium ASC Abutment |
|----------------------|-------------------------------------|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA |

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Image /page/5/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 the "TM" symbol in superscript.

### 1.3 Device Name No. 2

| Proprietary name: | Omnigrip Clinical Screw Titanium |
|----------------------|------------------------------------|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment Screw |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA |

### 1.4 Predicate Device

#### Primary Predicate Device No 1

| Proprietary name: | NobelProcera® Abutment Titanium (K091756) |
|----------------------|-------------------------------------------|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA |

#### Reference 1 for No. 1 Device

| Proprietary name: | NobelProcera Angulated Screw Channel Abutment Conica<br>Connection (K132746) |
|----------------------|------------------------------------------------------------------------------|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA |

#### Reference 2 for No. 1 Device

| Proprietary name: | DESS® Dental Smart Solutions (K221301) |
|----------------------|----------------------------------------|
| Manufacturer: | Terrats Medical SL |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |

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Image /page/6/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 black font. The word "Nobel" is on the top line, and "Biocare" is on the bottom line with a trademark symbol.

Product Code:

# Reference 3 for No. 1 Device

| Proprietary name: | Universal Abutment NB N1 TCC (K211109) |
|----------------------|----------------------------------------|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA. PNP |

NHA, PNP

#### Reference 4 for No. 1 Device

| Proprietary name: | NOBELACTIVE WIDE PLATFORM (WP) (K133731) |
|----------------------|------------------------------------------|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA |

#### Reference 5 for No. 1 Device

| Proprietary name: | Titanium Abutment Blank Nobel Biocare N1 TM TCC<br>(K223677) |
|----------------------|--------------------------------------------------------------|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR§872.3630 |
| Device Class: | II |
| Product Code: | NHA, PNP |

#### Predicate No. 2 Device

| Proprietary name: | Omnigrip Clinical Screw CC (K132746) |
|----------------------|--------------------------------------|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA |

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Image /page/7/Picture/0 description: The image contains the logo for Nobel Biocare. The logo consists of a stylized red letter "N" on the left, followed by the words "Nobel Biocare" in black text on the right. The word "Nobel" is on the top line, and the word "Biocare" is on the bottom line with a trademark symbol.

#### Reference 1 for No. 2 Device

| Proprietary name: | NOBELACTIVE MULTI UNIT ABUTMENT (K072570) |
|----------------------|-------------------------------------------|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA |

#### Reference 2 for No. 2 Device

| Proprietary name: | Trefoil System (K170135) |
|----------------------|------------------------------------|
| Manufacturer: | Nobel Biocare AB |
| Common Name: | Dental Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | II |
| Product Code: | NHA |

#### Reference for No. 1 Device & No. 2 Device

| 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 |
| Device Class: | II |
| Product Code: | DZE, NHA, PNP, DZI |

#### 1.5 Device Description Summary

The Subject Device NobelProcera® Titanium ASC Abutment is composed of two device lines: NobelProcera® Titanium ASC Abutment and the Clinical Screw Omnigrip Titanium.

NobelProcera® Titanium ASC Abutment is a patient matched CAD/CAM dental prosthesis which is connected to the Nobel Biocare implants featuring an internal conical and/or internal tri-channel connection, is available in the platform sizes NP, RP WP and

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Image /page/8/Picture/0 description: The image contains the logo for Nobel Biocare. On the left is a red symbol that looks like a stylized letter N. To the right of the symbol is the text "Nobel Biocare" in black. The word "Nobel" is on the top line, and the word "Biocare" is on the bottom line with a trademark symbol.

6.0 (for internal tri-channel connection only) and is intended for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance.

NobelProcera® Titanium ASC Abutments undergo patient matched customization at a Nobel Biocare production facility for the final, finished abutment device manufacturing.

NobelProcera® Titanium ASC Abutment is connected to the implant with a clinical screw and features an angulated screw channel which can be defined by the customer in an angulation (to the implant's axis) between 0° and 25°, in addition the abutment can be angulated to a maximum of 30°. The clinical screw features the Omnigrip Interface which allows tightening up to 25°.

NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium are composed of titanium vanadium alloy Ti6Al4V ELI (ISO 5832-3, ASTM F136) and the surface of the abutments are provided with and without anodization and the Omnigrip Clinical Screw Titanium are provided with and without DLC coating.

The finished NobelProcera® Titanium ASC Abutment supports the placement of a cement-retained dental prosthesis.

Table 1-1 outlines the restorative design specifications for the NobelProcera Titanium ASC Abutments:

| Subject Device | NobelProcera®<br>Titanium ASC<br>Abutment |
|--------------------------------------------------------------------------|-------------------------------------------|
| Maximum abutment anqulation | 30° |
| Minimum screw channel thickness (min. wall thickness) | 0.42 mm |
| Maximum abutment height from implant level | 15 mm |
| Minimum diameter | 4.4 mm |
| Maximum diameter | 16 mm |
| Minimum post height (length above the abutment collar / gingival height) | 4 mm |
| Maximum post height (length above the abutment collar / gingival height) | 14.7 mm |
| Minimum gingival margin height | 0.3 mm |

#### Table 1-1: Design Constraints

Omnigrip Clinical Screw Titanium is available for the NP, RP, WP and 6.0 (for internal tri-channel connection only) platform, the devices connect the NobelProcera Titanium ASC Abutments to the dental implants. The devices feature an Omnigrip interface. Table 1-2 outlines the design specifications for the Omnigrip Clinical Screw Titanium:

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Image /page/9/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".

#### Table 1-2: Omnigrip Clinical Screw Titanium Design Specifications

| Connection | Largest nominal diameter | Nominal total length: |
|-------------|-------------------------------|-------------------------------|
| Conical | NP: 2.3<br>RP/WP: 2.525 | NP: 7.325<br>RP/WP: 7.3 |
| Tri-Channel | NP: 2.465<br>RP/WP/6.0: 2.465 | NP: 8.315<br>RP/WP/6.0: 10.03 |

NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium are compatible with Nobel Biocare implants featuring an internal conical connection (K142260, K073142, K173418 and K202344) and internal tri-channel connection (K023113).

#### Intended Use/Indication for Use 1.6

NobelProcera® Titanium ASC Abutments:

NobelProcera® Abutment Titanium is a patient-matched CAD/CAM prosthetic component directly connected to endosseous dental implants and is indicated for use as an aid in prosthetic rehabilitation.

Omnigrip Clinical Screw Titanium:

Clinical and Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.

#### 1.7 Indications for Use Comparison

The Intended Use statement and Indications for Use statement are the same, expressed through a similar choice of words.

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Image /page/10/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 on the top line and the word "Biocare" is on the bottom line with a trademark symbol.

# 1.8 Technological Comparison

### 1.8.1 NobelProcera® Titanium ASC Abutments

### Table 1-3: NobelProcera Titanium ASC Abutment Predicate and Reference Device Summary

| | Subject Device | Primary Predicate<br>Device | Reference Device<br>#1 | Reference Device<br>#2 | Reference Device<br>#3 | | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| | NobelProcera<br>Titanium ASC<br>Abutment | NobelProcera®<br>Abutment Titanium | NobelProcera<br>Angulated Screw<br>Channel Abutment<br>Conical<br>Connection | DESS® Dental<br>Smart Solutions | Universal<br>Abutment NB N1<br>TCC | Comparison | |
| | | K091756 | K132746 | K221301 | K211109 | | |
| Manufacturer | Nobel Biocare AB | Nobel Biocare AB | Nobel Biocare AB | Terrats Medical SL | Nobel Biocare AB | | |
| Product Classification | Class II | Class II | Class II | Class II | Class II | Same as Primary Predicate | |
| Regulation Number /<br>Name | 21 CFR 872.3630<br>Endosseous Dental<br>Implant Abutment | 21 CFR 872.3630<br>Endosseous Dental<br>Implant Abutment | 21 CFR 872.3630<br>Endosseous Dental<br>Implant Abutment | 21 CFR 872.3630<br>Endosseous Dental<br>Implant Abutment | 21 CFR 872.3630<br>Endosseous Dental<br>Implant Abutment | Same as Primary Predicate | |
| Product Code, primary | NHA | NHA | NHA | NHA | NHA | Same as Primary Predicate | |
| Product Code,<br>secondary | N/A | N/A | N/A | PNP | PNP | Same as Primary Predicate | |
| Review Panel | Dental | Dental | Dental | Dental | Dental | Same as Primary Predicate | |
| Intended Use | Intended to be<br>finalized into a single-<br>unit dental prosthesis,<br>which is connected to<br>an endosseous dental<br>implant to restore<br>chewing function | Nobel Biocare's<br>NobelProcera®/Proce<br>ra® Abutment<br>Titanium/Zirconia is a<br>customized dental<br>abutment. The<br>abutment attaches<br>directly to the<br>endosseous dental<br>implant with a clinical<br>screw and provides a | Nobel Biocare's<br>NobelProcera®<br>ASC Abutment<br>Zirconia is a<br>customized dental<br>abutment. The<br>abutment is seated<br>and attached<br>directly to the<br>endosseous dental<br>implant and<br>provides a platform | Support of a<br>prosthesis to<br>restore chewing<br>function | Intended to be<br>connected to an<br>endosseous dental<br>implant to support<br>the placement of a<br>dental prosthesis. | Same Intended Use expressed<br>through a similar choice of<br>words. | |
| Subject Device | Primary Predicate<br>Device | Reference Device<br>#1 | Reference Device<br>#2 | Reference Device<br>#3 | Comparison | | |
| NobelProcera<br>Titanium ASC<br>Abutment | NobelProcera®<br>Abutment Titanium | NobelProcera<br>Angulated Screw<br>Channel Abutment<br>Conical<br>Connection | DESS® Dental<br>Smart Solutions | Universal<br>Abutment NB N1<br>TCC | | | |
| | K091756 | K132746 | K221301 | K211109 | | | |
| | | platform for<br>restoration. | for restoration. The<br>NobelProcera®<br>ASC Abutment<br>Zirconia is<br>individually<br>designed and<br>manufactured to<br>fulfill the clinical<br>need of each<br>patient.<br>The NobelProcera®<br>ASC Abutment<br>Zirconia is made out<br>of Zirconia and is<br>delivered<br>with a titanium<br>adapter and an<br>Omnigrip™ clinical<br>screw. | | | | |
| Indications for Use | NobelProcera®<br>Abutment Titanium is<br>a patient-matched<br>CAD/CAM prosthetic<br>component directly<br>connected to<br>endosseous dental<br>implants and is<br>indicated for use as<br>an aid in prosthetic<br>rehabilitation. | Nobel Biocare's<br>NobelProcera®/Proce<br>ra® Abutment<br>titanium/Zirconia is<br>indicated for the<br>treatment of partially<br>edentulous patients<br>requiring prosthetic<br>devices and/or<br>endosseous implants<br>to restore chewing<br>function. | The NobelProcera<br>Angulated Screw<br>Channel Abutment<br>Conical Connection<br>are<br>premanufactured<br>prosthetic<br>components directly<br>connected to<br>endosseous dental<br>implants and are<br>intended for use as<br>an aid in prosthetic<br>rehabilitation. | DESS Dental<br>Smart Solutions<br>abutments are<br>intended for dental<br>prosthetic<br>restorations. DESS<br>Dental Smart<br>Solutions<br>abutments are<br>used as an<br>interface between a<br>dental implant or<br>dental abutment<br>and a dental | Universal<br>abutments are<br>indicated to support<br>the placement of<br>single unit, screw-<br>retained prosthetic<br>restorations in the<br>maxilla or mandible.<br>The Universal<br>Abutment consists<br>of two major parts.<br>Specifically, the<br>titanium base and<br>mesostructure | Same Indications for Use<br>expressed through a similar<br>choice of words and adjusted to<br>match updated wording<br>according to FDA feedback in<br>prev. submissions (K220048). | |
| Subject Device | Primary Predicate<br>Device | Reference Device<br>#1 | Reference Device<br>#2 | Reference Device<br>#3 | | | |
| NobelProcera<br>Titanium ASC<br>Abutment | NobelProcera®<br>Abutment Titanium | NobelProcera<br>Angulated Screw<br>Channel Abutment<br>Conical<br>Connection | DESS® Dental<br>Smart Solutions | Universal<br>Abutment NB N1<br>TCC | Comparison | | |
| | K091756 | K132746 | K221301 | K211109 | | | |
| | | | restoration and will<br>be attached to the<br>implant or<br>abutment using a<br>prosthetic screw<br>and attached to the<br>dental restoration<br>by cementing.<br>All digitally<br>designed custom<br>abutments for use<br>with Base abutment<br>or Pre-milled Blank<br>are to be sent to a<br>Terrats Medical<br>validated milling<br>center for<br>manufacture, or to<br>be designed and<br>manufactured<br>according to the<br>digital dentistry<br>workflow. The<br>digital dentistry<br>workflow integrates<br>multiple<br>components: scan<br>files from intra-oral<br>and lab (desktop)<br>scanners, CAD<br>software, CAM<br>software, ceramic | components make<br>up a two-piece<br>abutment.<br>The system<br>integrates multiple<br>components of the<br>digital dentistry<br>workflow scan files<br>from Intra-Oral<br>Scanners, CAD<br>software, CAM<br>software, ceramic<br>material, milling<br>machine and<br>associated tooling<br>and accessories. | | | |
| Subject Device | Primary Predicate Device | Reference Device #1 | Reference Device #2 | Reference Device #3 | Comparison | | |
| NobelProcera<br>Titanium ASC<br>Abutment | NobelProcera®<br>Abutment Titanium | NobelProcera<br>Angulated Screw<br>Channel Abutment<br>Conical<br>Connection | DESS® Dental<br>Smart Solutions | Universal<br>Abutment NB N1<br>TCC | | | |
| | K091756 | K132746 | K221301<br>material, milling<br>machine, and<br>associated tooling<br>and accessories. | K211109 | | | |
| Technological<br>Characteristics | | | | | | | |
| Device Dimensions/<br>Design Specifications | | | | | | | |
| Minimum wall<br>thickness: | 0.42 mm | 0.3637mm | N/A | 0.4 mm | N/A | Similar to Primary Predicate. | |
| Platform<br>compatibility | Conical<br>Connection | NP, RP, WP | NP, RP | NP, RP | NP, RP, WP<br>(according to 510k<br>summary) | N/A | Similar to Primary Predicate.<br>Same as Reference Device #2 |
| | Tri<br>Channel<br>Connection | NP, RP, WP, 6.0 | NP, RP, WP, 6.0 | N/A | NP, RP, WP, 6.0<br>(according to 510k<br>summary) | N/A…