JENSEN GOLD FOIL

{0}------------------------------------------------ ## Section E 510(k) SUMMARY Kozadol Jensen Industries Submitted by: 50 Stillman Road North Haven CT 06473 (203) 239-2090 phone (203) 239-1015 fax Contact: John Slanski June 25, 2002 Date Prepared: Device Name: Common Name: Classification: Product Code: Jensen Gold Foil Direct filling gold foil Class II EJT Predicate Device(s): EZ Gold - K915626 Williams Gold Foil (pre-amendment device) Device Description: Jensen Gold Foil is pure gold, direct filling gold foil suitable for use by dentists in filling Class I, Class V, Class VI, and Pit dental preparations, Indications for use and chemical composition are identical to those of the predicate devices. There are no standards for direct filling gold foil. The safety and effectiveness of Jensen Gold Foil is based upon the centuries long clinical success of direct filling gold foil. Gold foil is the reference standard for biocompatibility and longevity. In the hands of a skilled operator, "there can be no doubt that a properly inserted direct gold restoration is unsurpassed from the standpoint of service."1 1 Phillips R.W. Skinner's Science of Dental Materials. 8th ed. Philadelphia: WB Saunders, 1982:366. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design. The eagle's wings are represented by curved lines that also form the profiles of three faces. AUG 2 9 2002 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. John Slanksi Manager, Research & Development Jensen Industries, Incorporated 50 Stillman Road North Haven, Connecticut 06473 Re: K022206 Trade/Device Name: Jensen Gold Foil Regulation Number: 21 CFR 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: June 25, 2002 Received: July 05, 2002 Dear Mr. Slanksi: 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. {2}------------------------------------------------ ## Page 2 – Mr. Slanksi 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 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" (21CFR 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.gov/cdrh/dsma/dsmamain.html Sincerely yours Timothy A. Ulatowski Timoth v A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use Statement .. . . . Ver/ 3 - 4/24/96 | Applicant: | Jensen Industries Incorporated | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number (if known): | K022206 | | Device Name: | Jensen Gold Foil | | Indications For Use: | Jensen Gold Foil is pure gold direct filling gold foil suitable for use by dentists in filling Class I, Class V, Class VI, and Pit dental preparations. | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96)  (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | 510(k) Number: | K022206 | |----------------|---------| |----------------|---------| {Ref DCF 2721}