3i Dental Accessories - 510K Submissions

3i Dental Accessories
Statement Letter
Ms. Jeanette G. Dailey
Regulatory Affairs Manager
Implant Innovations, Incorporated
4555 Riverside Drive
Palm Beach Gardens, Florida 33410
Re: KO221 13
Trade/Device Name: 3 i Dental Implant Accessories
Regulation Number: 872.3640
Regulation Name: Endosseous Dental Implant
Regulatory Class: I11
Product Code: DZE
Dated: June 27,2002
Received: June 28,2002
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 I1 (Special Controls) or class 111 (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 89s. I n addition, FDA may publish further announcements concerning your device in the Federal Register.
Pleasc be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device coniplies 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 53 1-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 5 1 O(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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2 1 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. qov/cdrh/dsma/dsmamain. html
Sincerely yours,
Timothy A. Ulatowski
Director
Division of Anesthesiology, General Hospital,
Office of Device Evaluation
Center for Devices and
Radiological Health
Infection Control and Dental Devices
Summary Information:
Implant Innovations, Inc.
4555 Riverside Drive
Palm Beach Gardens, FL 33410
Jeannette G. Dailey, RAC
Regulatory Affairs Manager
Telephone: 56 1-776-69 13
Fax: 56 1-776-6852
E-mail : j daile y (9 3implant. com
June 27,2002
3i Dental Accessories
DZE Class I11
Endosseous Dental Accessories
3i Dental Accessories cleared for marketing
via the following premarket notifications:
K935544 - 3i Implants
K952811 - 3i OralMaxillofacial Bone Fixation System
K962014 - 3i Single Use,
Disposable Drills, Taps, Burs
K962465 - TIL3 13 Abutment and Retaining Screw System
K965077 - Single Tooth Abutment System
K992334 - Endosseous Implants and Abutments
KO1291 1 - 3i Locater Abutment System
KO13570 - OSSEOTITEB Dental Implant System
DEVICE DESCRIPTION:
Dental implants are surgically inserted into the upper and/or lower jawbone and are left to heal (osseointegrate) with the bone for a period of up to six months. Upon healing and integration with the bone, the cover screw or healing abutment (if used) is removed, impressions are taken, and either a transmucosal abutment (which will later be attached to a custom prosthesis) or an emergence profile (EP) healing abutment is attached to the implant. The soft tissues are allowed to heal around the abutment forming the soft tissues to the contours of the abutment Çƒ?emergenceÇƒ? profiling. The implant becomes the
artificial root structure for a prosthetic tooth or as an abutment structure for bridge work and/or denture retention.
Implant InnovationÇƒÙs dental accessories are available in a wide range of sizes; and are manufactured from various materials. This premarket notification relates to marketing previously non-sterile 3i dental
accessories as sterile for user convenience. The devices are packaged in sterilization- compatible packaging (heat-sealed nylon pouch) and sterilized by gamma irradiation. There are no changes to the design, materials, or the Indications for Use for the accessories.
INDICATIONS FOR USE:
Implant Innovation, Inc., 34 Dental Implants and Accessories are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patientÇƒÙs chewing function.