NOBELPROCERA TI ABUTMENT

K091756 · Nobel Biocare AB · NHA · Sep 22, 2009 · Dental

Device Facts

• Record ID: K091756
• Device Name: NOBELPROCERA TI ABUTMENT
• Applicant: Nobel Biocare AB
• Product Code: NHA · Dental
• Decision Date: Sep 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NobelProcera Ti Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

Device Story

NobelProcera Ti Abutment is an endosseous dental implant abutment. Device attaches directly to endosseous dental implants to provide a platform for dental restoration. Abutments are custom-designed and manufactured to meet individual patient requirements. Used by dental professionals in clinical settings to facilitate prosthetic rehabilitation. Benefits include providing a stable interface between the dental implant and the final prosthetic restoration.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Materials: Titanium or titanium/vanadium alloy. Form factor: Custom-designed endosseous dental implant abutment. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for patients requiring prosthetic rehabilitation via endosseous dental implants. Used as a premanufactured prosthetic component connected directly to the implant.

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

• Procera ® Abutment Brånemark (K042658)
• Procera ® Implant Bridge Overdenture (K090064)
• SFB and CFB Angled Abutments (K062749)

Submission Summary (Full Text)

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SEP 2 2 2009

K091756

#### 510(k) Summary of Safety and Effectiveness 1.4

| Submitted by: | Herbert Crane, Director Global Regulatory Affairs |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
| Telephone: | [phone], ext. 5074 |
| Facsimile: | [phone] |
| Date of Submission: | June 12, 2009 |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Trade or Proprietary<br>or Model Name: | NobelProcera Ti Abutment |
| Legally Marketed Devices: | Nobel Biocare - Procera ® Abutment Brånemark (K042658)<br>Nobel Biocare - Procera ® Implant Bridge Overdenture (K090064)<br>Nobel Biocare - SFB and CFB Angled Abutments (K062749) |

### Device Description:

Nobel Biocare's NobelProcera Ti Abutment is an endosseous dental implant abutment. The Nobel Biocare's NobelProcera Ti Abutment attaches directly to endosseous dental implants and provides a platform for restoration.

Nobel Biocare's NobelProcera Ti Abutments are designed and made individually to fit the individual requirements for each patient. The NobelProcera Ti Abutments are made entirely of titanium or titanium/vanadium alloy.

#### Indications for Use:

The NobelProcera Ti Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

Nobel Biocare Traditional 510(k) Notification NobelProcera Ti Abutment (additional platforms) June 2009

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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SEP 2 2 2009

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

Nobel Biocare AB C/O Mr. Herbert Crane Director, Global Regulatory Affairs Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K091756

Trade/Device Name: NobelProcera Ti Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 12, 2009 Received: June 25, 2009

#### Dear Mr. Crane:

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.

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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## Page 2- Mr. Crane

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Reporta Problem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

h fo

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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K091756

# Indications for Use

1.3

510(k) Number (if known):

Device Name: NobelProcera Ti Abutment

Indications For Use:

The NobelProcera Ti Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

Prescription Use X … (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)

Re-Mulin for MSR

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K091756