NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE

K133377 · Nobel Biocare AB · NHA · Apr 4, 2014 · Dental

Device Facts

• Record ID: K133377
• Device Name: NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE
• Applicant: Nobel Biocare AB
• Product Code: NHA · Dental
• Decision Date: Apr 4, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NobelProcera Angulated Screw Channel Abutment Replace are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

Device Story

NobelProcera Angulated Screw Channel Abutment Replace is a patient-specific, two-piece endosseous dental implant abutment; attaches to Nobel Biocare dental implants via conical connection. Components include titanium-vanadium alloy adapter and zirconium oxide abutment portion. Screw channel allows 0° to 25° angulation. Used in oral cavity by dental professionals to provide platform for prosthetic restoration. Device is machined to individual patient requirements. Benefits include improved prosthetic positioning and restoration of chewing function.

Clinical Evidence

Bench testing only; no clinical data provided. Fatigue testing performed in accordance with FDA guidance 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments'.

Technological Characteristics

Two-piece design; adapter: titanium-vanadium alloy; abutment: zirconium oxide. Conical connection to implant. Variable screw channel angulation (0°-25°). Patient-specific machined form factor. Non-sterile (implied by premanufactured prosthetic component classification).

Indications for Use

Indicated for use as an aid in prosthetic rehabilitation for patients requiring prosthetic devices and/or endosseous implants to restore chewing function.

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

• Esthetic Zirconia Abutment (K031719)

Submission Summary (Full Text)

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## APR 0 4 2014

#### 510(k) Summary 1.4

| Submitted by: | Phuong Nguyen<br>Senior Regulatory Affairs Manager<br>Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Submitted for: | Nobel Biocare AB<br>Vastra Hamngatan 1<br>Goteborg, SE 411 17<br>Sweden |
| Telephone: | [phone] x7830 |
| Facsimile: | [phone] |
| Date of Submission: | November 1, 2013 |
| Classification Name:<br>Pro Code: | Endosseous Dental Implant Abutment (21 CFR 872.3630)<br>NHA |
| Trade or Proprietary<br>or Model Name: | NobelProcera Angulated Screw Channel Abutment Replace |

Legally Marketed Devices: Nobel Biocare - Esthetic Zirconia Abutment (K031719)

#### Device Description:

Nobel Biocare's NobelProcera Anquiated Screw Channel Abutment Replace is an endosseous dental implant abutment. The abutment attaches directly to Nobel Biocare dental implants with a conical connection and provides a platform for restoration.

Nobel Biocare's NobelProcera Angulated Screw Channel Abutment Replace is designed and made individually to fit the individual requirements for each patient. The abutments are a two piece design with an adapter portion made of titanium vanadium alloy and an abutment portion made of zirconium oxide. The screw channel can be angulated between 0° and 25° as required.

#### Indications for Use:

The NobelProcera Angulated Screw Channel Abutment Replace are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

#### Summary of testing to demonstrate safety and effectiveness

Non-clinical test data was used to support the decision of safety and effectiveness. Clinical testing was not necessary. Non-clinical testing consisted of performance of fatigue testing in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.

Nobel Biocare Traditional 510(k) Notification NobelProcera ASC Abutments Rpl November 2013

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omparison of Technological Characteristics

.

| ATTRIBUTE | CANDIDATE | PREDICATE |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design/ construction | Nobel Procera Angulated Screw Channel Abutment<br>Replace | Esthetic Zirconia Abutment (K031719) |
| | Patient specific / machined | Patient specific / machined |
| Anatomical Site | Oral Cavity | Oral Cavity |
| Platform compatibility | Nobel Biocare<br>- Replace | Nobel Biocare<br>- Branemark<br>- Replace |
| Screw Channel | Variable 0° to 25° | Fixed 0° |
| Device Material | Implant Adapter<br>- Titanium/vanadium alloy | Zirconium oxide |
| Indications for Use | The NobelProcera Angulated Screw Channel Abutment<br>Replace are premanufactured prosthetic components<br>directly connected to endosseous dental implants and are<br>intended for use as an aid in prosthetic rehabilitation. | Nobel Biocare's Esthetic Zirconia Abutment is indicated for<br>the treatment of partially edentulous patients requiring<br>prosthetic devices and/or endosseous implants to restore<br>chewing function. |

Conclusion

·

Conclusion
The information provided in this submission demonstrates that the device is substantially equivalent to the predicate device

Nobel Biocare Traditional 510(k) Notification
NobelProcera ASC Abutments Rpl
November 2013

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

### April 4, 2014

Nobel Biocare AB C/O Phuong Nguyen Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887

Re: K133377

Trade/Device Name: NobelProcera Angulated Screw Channel Abutment Replace Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 25, 2014 Received: March 5, 2014

Dear Ms. Nguyen:

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. 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.

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 or any I outlar states and the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Nguyen

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): ךךך 333

Device Name: NobelProcera Angulated Screw Channel Abutment Replace

Indications For Use:

The NobelProcera Angulated Screw Channel Abutment Replace are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A. Greer 2014.04.02 15:03:28 -04'00'

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