CARRARA VOLUMIA

{0}------------------------------------------------ K070019 ## SECTION 5: 510(k) SUMMARY JAN 2 6 2007 DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872 | CONTACT: | Helen Lewis | |----------------------------|----------------------------------------------| | DATE PREPARED: | January 2, 2007 | | TRADE OR PROPRIETARY NAME: | Carrara Volumia Ceramic System | | CLASSIFICATION NAME: | Porcelain powder for clinical use (872.6660) | | PREDICATE DEVICES: | Carrara Interaction Ceramic System. K040635 | DEVICE DESCRIPTION: The Carrara Volumia Ceramic System is a dental porcelain system used for the preparation of fixed prosthodontic devices. INTENDED USE: Carrara Volumia Ceramic System is indicated for the veneering of metalceramic or full ceramic restorative systems. TECHNOLOGICAL CHARACTERISTICS: All of the components found in Carrara Volumia Ceramic System have been used in legally marketed devices and were found safe for dental use. Carrara Volumia Ceramic System has been evaluated and passed biocompatibility testing for cytotoxicity. We believe that the prior use of the components of Carrara Volumia Ceramic System in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of Carrara Volumia Ceramic System for the indicated uses. Premarket Notification {1}------------------------------------------------ Public Health Service Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the emblem. ... JAN 2 6 2007 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872 Re: K070019 Trade/Device Name: Carrara Volumia Ceramic System Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: January 02, 2007 Received: January 03, 2007 Dear Ms, Lewis: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your bootion 910(x) production is substantially equivalent (for the indications for relerenced above and nave decommined as as a seed predicate devices marketed in interstate commerce use stated in the encreated to the Medical Device Amendments, or to devices that provision in way 20, 1970, the ensearce with the provisions of the Federal Food, Drug, and Cosmetic liave occiricelassified in acceration of a premarket approval application (PMA). You may, Act (Act) that ao not require approvat othe general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good controls provisions of and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n your device to such additional controls. Existing major regulations affecting your device can be may be subject to sublicitions. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {2}------------------------------------------------ ## Page 2 - Ms. Helen Lewis 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 (OS) 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Suyite Y. Michie DMD. Chiu S. Lin. PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## SECTION 4: INDICATIONS FOR USE 510(k) Number (if known): K070019 Device Name: Carrara Volumia Ceramic System Indications for Use: Carrara Volumia Ceramic System is indicated for veneering of metal-ceramic or full ceramic restorative systems. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Kei Muluy for MSe CA POSDED Premarket Notification Carrara Volumia Ccramic System DENTSPLY International 7