(85 days)
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.
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.
The provided text is a 510(k) summary and related correspondence for the Nobel Biocare Endosseous Implants for Maxillofacial Indication. This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it is focused on extending an existing indication.
Therefore, I cannot provide the requested information from the given text.
The document indicates that the device is substantially equivalent to legally marketed predicate devices, meaning it does not require new performance studies to demonstrate safety and effectiveness for the extended indication. Instead, the focus is on the device description and its intended use.
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510(k) Summary of Safety and Effectiveness 1.4
| Submitted by: | Herbert CraneDirector, Global Regulatory Affairs | JUN - 2 2009 |
|---|---|---|
| Address: | Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887 | |
| Telephone: | (714) 282-5074 | |
| Facsimile: | (714) 998-9348 | |
| Date of Submission: | March 6, 2009 | |
| Classification Name: | Nose Prosthesis (21 CFR 878.3680) | |
| Trade or Proprietaryor 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
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.
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 (800) 638-2041 or (240) 276-3150 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
Page 1 of 1
510(k) Number K090630
§ 878.3680 Nose prosthesis.
(a)
Identification. A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.(b)
Classification. Class II.