WILLI GELLER CREATION II PORCELAIN

{0}------------------------------------------------ K043468 ## 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) 234-7176 fax<br>Contact: Gary Phelps | |------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared: | December 14, 2004 | | Device Name:<br>Common Name:<br>Classification:<br>Product Code: | Willi Geller Creation TI Porcelain<br>Dental Porcelain<br>Class II<br>EIH | | Predicate Devices: | Willi Geller Creation& LF Porcelain: 510(k) number K00290 | ## Device Description Williw Geller Creation TI porcelain is a dental ceramic that is used by dental technicians to fabricate dental restorations by veneering of titanium alloy cores. Data has been presented to demonstrate that the mechanical properties, chemical qualities, and the indications for use make Willi Geller Creation TI substantially equivalent to the predicate device Willi Geller Creation& LF Porcelain. The safety and effectiveness of Willi Geller Creation TI , being determined by the chemical qualities and mechanical properties, is therefore equivalent to the predicate devices. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem of a stylized caduceus, which is a symbol often associated with healthcare and medicine. The caduceus in the logo features a staff with two snakes entwined around it, topped with a pair of wings. JAN 1 2 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Gary Phelps Quality Assurance Manager Jensen Industries, Incorporated 50 Stillman Road North Haven, Connecticut 06473 Re: K043468 Trade/Device Names: Willi Geller Creation TI Porcelain Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: December 14, 2004 Received: December 16, 2004 Dear Mr. Phelps: 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. Gary Phelps 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 (240) 276-0115. 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, 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K043468 Device Name: Willi Geller Creation TI Porcelain Indications for Use: Willi Geller Creation TI Porcelain is a ceramic material intended for veneering of titanium alloy cores and substructures to form dental restorations. Prescription Use × (21 CFR Part 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR Part 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan R (Division Sign-Off) Civision of Anesthesiology, General Hospital, Infection Control, Dental Devices Page 1 of __1__ 510(k) Number ________________________________________________________________________________________________________________________________________________________________