HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT

{0}------------------------------------------------ K040714 ## 510(K) SUMMARY FOR THE INNOVA CORPORATION HYBRID ENDOPORE IMPLANT # APR - 9 2004 ## Submitter's Name, Address, Telephone Number, And Contact Person 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 Endosscous 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). #### Intended Use The Endopore Implant is indicated for use in the upper or lower jaw arches to provide support for a dental prosthesis. {1}------------------------------------------------ ## Principles of Operation The principles of operation of the modified device are identical to the previously cleared Endopore Implant System except for the direct placement of the implant in the manner of a threaded-screw design. ## 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. ## Summary Basis for the Finding of Substantial Equivalence The minor modification to the surface of the Endopore Implant does not alter its indications for use or its fundamental scientific technology. Therefore, the modified device is substantially equivalent to the predicates. {2}------------------------------------------------ Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR - 9 2004 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. {3}------------------------------------------------ Page 2 - Mr. Holstein 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 recuirements 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 vours. f. H. Welch for, 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 Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: Hybrid Endopore® Endosscous Dental Implant System Indications For Use: For use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices. Prescription Use __ X (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) Dr. Robert Sheetz, DDS for Dr. S. Kumar (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: Page 1 of 1