Hybrid Endopore¨? Endosseous Dental Implant System

Hybrid Endopore¨? Endosseous Dental Implant System
Statement Letter:
Innova LifeSciences Corporation
Mr. Howard M. Holstein
C/O Mr. Hogan & Hartson L.L.P.
555; Thirteenth Street N.W.
Washington D.C. 20004
Re: K040714
Trade/Device Name: Hybrid Endopore¨? Endosseous Dental Implant System
Regulation Number: 872. 3640
Regulation Name: Endosseous Implant
Regulatory Class: III
Product Code: DZE
Dated: March 17, 2004
Received: March 18, 2004
Dear Mr. Holstein:
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 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) 594-5613. 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,
Chiu 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:
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
February 25, 2004
Name of the Device
Hybrid Endopore¨? Endosseous Dental Implant System
Common or Usual Name
Endosseous Implant
Classification Name
Endosseous Implant (DZE)
Predicate Devices
Endopore¨? Endosseous Dental Implant System in 4.1 mm diameter
(K926354) and 5.0 mm diameter (K971196); 5 mm long x 5.0 mm diameter
Endopore Endosseous Dental Implant System (K032140).
Inten(ded 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 Hybrid Endopore Implant also are identical to the predicates, except for the addition of three selftapping threads in the coronal region of the implant. The dimensions of the modified Hybrid Endopore Implant, 9.5 mm and 11 mm in length x 4.0 mm diameter; and 7.5 mm and 9.5 mm in length x 5.0 mm diameter, are very similar to the dimensions of previously cleared Endopore implants.