NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)

K090630 · Nobel Biocare AB · FZE · Jun 2, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090630
• Device Name: NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)
• Applicant: Nobel Biocare AB
• Product Code: FZE · General, Plastic Surgery
• Decision Date: Jun 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Nobel Biocare Endosseous Implants are indicated for maxillofacial use. They are intended to be used as the foundation for anchoring prosthesis or epithesis in the craniofacial region.

Device Story

Nobel Biocare Endosseous Implants serve as surgical anchors for maxillofacial prostheses or epitheses in craniofacial region. Device functions as foundation for external prosthetic attachment. Used by surgeons in clinical/hospital settings for reconstructive procedures. Provides stable osseointegrated base for facial prosthetics, improving patient aesthetic and functional outcomes following surgery or trauma.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarity to legally marketed predicate device.

Technological Characteristics

Endosseous implants; design and materials identical to previously cleared dental implants. Intended for craniofacial anchoring.

Indications for Use

Indicated for patients requiring maxillofacial reconstruction; intended as foundation for anchoring prosthesis or epithesis in craniofacial region.

Regulatory Classification

Identification

A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.

Predicate Devices

• Nobel Biocare - BA-CPAS (K945154)

Submission Summary (Full Text)

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K090630

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

| Submitted by: | Herbert Crane<br>Director, Global Regulatory Affairs | JUN - 2 2009 |
|----------------------------------------|----------------------------------------------------------------------------|--------------|
| Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 | |
| Telephone: | [phone] | |
| Facsimile: | [phone] | |
| Date of Submission: | March 6, 2009 | |
| Classification Name: | Nose Prosthesis (21 CFR 878.3680) | |
| Trade or Proprietary<br>or Model Name: | Nobel Biocare Endosseous Implants (Maxillofacial Indication) | |
| Legally Marketed Devices: | Nobel Biocare - BA-CPAS (K945154) | |

### Device Description:

This submission extends the indication for the Nobel Biocare Endosseous Implants to use in maxillofacial reconstructive surgery. There is no change to existing product marketed for dental applications.

### Indications for Use:

Nobel Biocare Endosseous Implants are indicated for maxillofacial use. They are intended to be used as the foundation for anchoring prosthesis or epithesis in the craniofacial region.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

JUN - 2 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K090630

Trade/Device Name: Nobel Biocare Endosseous Implants (Maxillofacial Indication) Regulation Number: 21 CFR 878.3680 Regulation Name: Nose Prosthesis Regulatory Class: II Product Code: FZE Dated: May 15, 2009 Received: May 18, 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.

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

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Page 2- Mr. Herbert Crane

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/cdrh/comp/ 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mello

Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

1090630

Device Name: Nobel Biocare Endosseous Implants (Maxillofacial Indication)

Indications For Use:

Nobel Biocare Endosseous Implants are indicated for maxillofacial use. They are intended to be used as the foundation for anchoring prosthesis or epithesis in the craniofacial region.

X 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)

David Krone for Mayor

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K090630