SARGON IMMEDIATE LOAD IMPLANT, MODEL D

{0}------------------------------------------------ KAS1141 EXHIBIT 6 ## 510(k) Summary Submitted by: Daniel J. Manelli Farkas & Manelli, P.L.L.C. 1233 20th Street, NW (Suite 700) Washington, DC 20036 202-261-1000 > On behalf of Sargon Enterprises, Inc. 510(k) Submission: Sargon Immediate Load Implant Alternate collar design March 27, 1998 The product is an endosseous dental implant for prosthetic attachment; trade name: Sargon Immediate Load Implant™. It is substantially equivalent to previously marketed models of this device described in premarket notifications K930071 and K961005. In this design, the collar is longer and allows the direct fixation of a prosthesis to the implant with or without the use of an abutment. The material is the same as the predicate devices; i.e., titanium alloy conforming to ASTM standard F136 "Standard Specification for Wrought Titanium 6Al-4V Ell Alloy for surgical Implant Applications." The indications for use are likewise identical: For use in either partially or fully edentulous mandibles and maxillae as a final or intermediary abutment for fixed or detachable prosthesis, and for use in support of free-standing restorations with or without the involvement of adjacent dentition. {1}------------------------------------------------ Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines that suggest a head and wings. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 2 3 1999 Sargon Enterprises, Incorporated c/o Mr. Daniel J. Manelli Farkas & Manelli, P.L.L.C. 2000 M Street North West 7th Floor Washington, DC 20036-3307 Re : K981141 Sargon Immediate Load Implant Model D Trade Name: Requlatory Class: III Product Code: DZE March, 25 1999 Dated: Received: Maarch 29, 1999 Dear Mr. Manelli: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. {2}------------------------------------------------ Page 2 - Mr. Manelli Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 requlation entitled, "Misbranding by reference to ene regaration Choroson" (21 CFR 807.97) Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## EXHIBIT A Page 1 of 1 K981141 510(k) Number (if known): Sargon Immediate Load Implant - Ultratooth Model Device Name: Indications for use: For immediate load use, without an abutment, in either partially or fully edentulous mandibles and maxillae, for fixed or detachable prosthesis and for use in support of free-standing restorations with or without the involvement of adjacent dentition. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription use | <div style="display:inline-block;">✓</div> | |----------------------|--------------------------------------------| | (Per 21 CFR 801.109) | | OR | Over-The Counter Use | | |--------------------------|--| | (Optional Format 1-2-96) | | Susan Pearson (Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices | 510(k) Number | 198191 | |---------------|--------| |---------------|--------|