3i Patient-Specific Dental Abutments and Overdenture Bars

3i Patient-Specific Dental Abutments and Overdenture Bars
Statement Letter:
Ms. Jeannette G. Dailey
Regulatory Affairs Manager
implant innovations, Incorporated
4555 Riverside Drive
Palm Beach Gardens, Florida 33410
Re: K032263
Trade/Device Name: 3i Patient-Specific Dental Abutments and Overdenture Bars
Regulation Number: 21 CFR 872.3640
Regulation Name: Endosseous Implant
Regulatory Class: III
Product Code: DZE
Dated: October 29, 2003
Received: October 30, 2003
Dear Ms. Dailey:
We have reviewed your Section 5 10(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 such 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 and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chu Lin, Ph., D.
Director
Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Summary Information:
COMPANY: Implant Innovations, Inc.
4555 Riverside Drive
Palm Beach Gardens, FL 33410
CONTACT: Jeannette G. Dailey, RAC
Regulatory Affairs Manager
Telephone: 561-776-6913
Fax: 561-776-6852
E-mail: jdailey@3implant.com
DATE PREPARED: July 21, 2003
NAME OF THE DEVICE: 3i Patient-Specific Dental Abutment; 3i Patient-Specific Overdenture Bar
CLASSIFICATION: DZE Class III
COMMON NAME: Dental Abutments
DEVICE DESCRIPTION:
The 3i Patient-Specific Dental Abutments and Overdenture Bars are designed to match individual patients.
INDICATIONS FOR USE:
The 3i Patient-Specific Dental Abutment and Overdenture Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.