R&D DESIGNATION AP-052-5

{0}------------------------------------------------ K032267 ## Section E ## 510(k) SUMMARY | Submitted by: | Jensen Industries<br>50 Stillman Road<br>North Haven CT 06473<br>(203) 239-2090 phone<br>(203) 239-1015 fax<br>Contact: John Slanski | |------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared: | July 18, 2003 | | Device Name:<br>Common Name:<br>Classification:<br>Product Code: | R&D designation AP-052-5<br>Dental alloy, precious metal for porcelain-fused-to-metal<br>Class II<br>EJT | | Predicate Device(s): | Helioform - K990670 | Device Description: AP-052-5 is a high-noble, gold based alloy suitable for use with the porcelain-fusedto-metal technique of fabricating dental restorations. . Data has been presented to demonstrate that the mechanical and physical properties of AP-052-5 make it substantially equivalent to the predicate device listed, and therefore it is suitible for use as a substrate for single unit restorations in the anterior region. Biocompatability of AP-052-5 has been assesed according to International Standard ISO 10993-1. The safety and effectiveness of AP-052-5 is therefore determined to be equivalent to the predicate device. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows a black and white logo. The logo consists of a circle with a stylized image of three birds flying inside. The birds are depicted with curved lines, suggesting movement or flight. The circle is not a solid line, but rather a series of small, connected shapes. **Food and Drug Administration** 9200 Corporate Boulevard Rockville MD 20850 SEP 1 7 2003 Mr. John Slanski Manager, Research & Development Jensen Industries. Incorporated 50 Stillman Road North Haven, Connecticut 06473 Re: K032267 Trade/Device Name: R&D Designation AP-052-5 Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical use Regulatory Class: II Product Code: EJT Dated: July 21, 2003 Received: August 5; 2003 Dear Mr. Slanski: 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 - Mr. Slanski 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) 594-4613. 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, Susan Runne Susan Runner, DDS, MA Interim 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 Jensen Industries Incorporated Applicant: 510(k) Number (if known): Device Name: R&D designation AP-052-5 Indications For Use: AP-052-5 is a high-noble, gold based alloy suitable for use with the porcelainfused-to-metal technique of fabricating dental restorations. The mechanical and rated to moter veemmake AP-052-5 suitable for use as a substrate for single unit restorations in the anterior region (Bicuspids, cuspids, and incisors) (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 Sian-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental De 510(k) Number: