5.0 x 5mm Endopore@ Endosseous Dental Implant System

5.0 x 5mm Endopore@ Endosseous Dental Implant System
Statement Letter:
Innova Life Sciences Corporation
Mr. Howard M. Holstein
Regulatory Counsel
Hogan & Hartson, L.L.P.
555 13'h Street N.W.
Washington, DC 20004
Re: KO32140
Trade/Device Name: 5.0 x 5mm Endopore@ Endosseous Dental Implant System
Regulation Number: 872.3 640
Regulation Name: Endosseous Implant
Regulatory Class: 111
Product Code: DZE
Dated: July 11,2003
Received: July 11,2003
Dear Mr. Holstein:
We have reviewed your Section 5 1 O(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 recdassified 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 I11 (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 (2 1 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 Sol), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2 1 CFR 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
httD ://www. fda.gov/cdrh/dsma/dsmamain. html
Sincerely yours,
Susan Runner, DDS, MA
Interim Director
Division of Anesthesiology, General Hospital
Office of Device Evaluation
Center for Devices and
Radiological Health
Innova Lifesciences Corporation
525 University Avenue, Suite 777
Toronto, Ontario M5G 2L3
Canada
Contact: Michael A. Kehoe, President
Telephone: (416) 340-8818
Facsimile: (416) 340-0415
Date Prepared June 30. 2003
Name of the Device
5.0 x 5 mm EndoporeO Endosseous Dental implant. System
Commo-n or Usual Name
Endosseous Implant
C1assification Name
Endosseous Implant (D ZE)
Intended Use
The Endopore Implant is indicated for use in the upper or lower jaw arches to provide support for a dental prosthesis.
Technological Characteristics
The technological characteristics of the modified Endopore Implant also are identical to the predicate endopore Implant System, except for the addition of a shorter implant length (5 mm) of the 5.0 mm diameter implant size. The device consists of the implant (root component), collar, collar retaining screw, coping,
coping retaining screw, healing cap, and healing cap retaining screw. Alternatively, the overdenture abutment (with an overdenture abutment retaining screw) is available; this assembly incorporates the coping. coping retaining screw, collar. and collar retaining screw into a combined component for attachment. to t,hc root component,. All of the component parts of the Endopore Implant, are fabricated from a surgical grade (ASTM F 136-9) titanium-aluminum-vanadium (Tic;Al.rl? alloy. The bone-contacting portion of' the implant component has a powder-sint,crcd porous coating of a surgical grade titanium-aluminum-vanadium alloy. The bonecontacting portion of t,he implant component is a t,runcated conic:i]l design wi t.11
tapered sides.