APOLLO, MODEL 1124525

{0}------------------------------------------------ K020949 Sterngold Special 510(k) Premarket Notification: Abbreviated 510(k) APR = 4 2002 March 15, 2002 Apollo # 510(k) Summary Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Sterngold is required to submit with this Premarket Notification either an " ... adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." Sterngold chooses to submit a summary of the safety and effectiveness information. The summary is as follows: | Trade Name: | Apollo | |----------------------|-----------------------------------------------------------------------------------------------------------------| | Sponsor: | Sterngold<br>23 Frank Mossberg Drive<br>P.O. Box 2967<br>Attleboro, MA 02703-0967<br>Registration #2921595 | | Device Generic Name: | Dental Alloy | | Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II. | #### Predicate Devices: | Alloy Name | 510(k) | Manufactured By | |------------|-----------|-----------------------| | Minigold | (k)905326 | Ivoclar North America | | Suncast | (k)923720 | Jelenko | | Select 40 | (k)895069 | Leach & Dillon Co. | #### Product Description: Apollo is a yellow Crown and Bridge Alloy. #### Indications for Use: Precious alloy for use in Crown and Bridge dental restorations. #### Safety and Performance: This submission is an Special 510(k): Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Sterngold has provided information to demonstrate conformity with FDA's guidance document entitled Guidance Document for the Preparation of Premarket Notifications [510(k) 3] for Dental Alloys). #### Conclusion: Based on the indications for use, technological characteristics, and comparison to predicate devices, Apollo has been shown to be safe and effective for its intended use. {1}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration. 9200 Corporate Boulevard Rockville MD 20850 Ms. Maria Rao Quality Manager Sterngold 23 Frank Mossberg Drive Attleboro, Massachusetts 02703-0967 ## APR = 4 2002 Re: K020949 Trade/Device Name: Apollo Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: Class II Product Code: EJT Dated: March 15, 2002 Received: March 25, 2002 Dear Ms. Rao: 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. {2}------------------------------------------------ Page 2 - Ms. Rao Please be advised that FDA's issuance of a substantial equivalence determination does not r least 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. or the recor any 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 and insting (2) see t 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, Timoth A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Sterngold Special 510(k) Premarket Notification: Abbreviated 510(k) Page 1 of 510(k) Number (if known): Device Name: Apollo Indications for Use: Precious Alloy for use in Crown and Bridge Dental Restorations. ### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Over-the -Counter Use __ OR (Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices 510(k) Number J