COLORISE RIGID

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three bars instead of one. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## MAY 1 4 2008 Zhermack S.p.A. C/O Mr. Gerald W. Shipps Regulatory Affairs Consultant Cascades Device Consulting Associates 19379 Blue Lake Loop Bend, Oregon 97702 Re: K081084 Trade/Device Name: COLORISE RIGID Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: April 14, 2008 Received: April 17, 2008 Dear Mr. Shipps: 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. {1}------------------------------------------------ Page 2 -- Mr. Shipps 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 promarket 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/industry/support/index.html. Sincerely yours, Ove Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image contains the logo for "Zhermack BEYOND INNOVATION". The logo is in black and white and features the company name in a bold, sans-serif font. Below the name is the tagline "BEYOND INNOVATION" in a smaller font. To the right of the text is a graphic design element consisting of two overlapping parallelograms. INDICATIONS FOR USE 510(k) Number (if known): Device Name: COLORISE RIGID Indications for Use: COLORISE RIGID is a conventional two-component (base/catalyst) polyvinylsiloxane (VPS) dental impression material intended to be placed on a preformed impression tray and used to reprocluce the structure of a patient's teeth and gums. Prescription Use V AND/OR ે પ Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDELL) Concurrence of CDRH, Office of Device Evaluation (ODE) Suan Runner (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: YC081051 COLORISE RIGID Rev. 0 April 10, 2008 Page 1 of 1 Zhermack SpA - Via Bovazecchino, 100 - 45021 Badia Polesine (Rovigo) Italy - tel. +39 0425 597611 - fax +39 0425 53596 11 - 12 - 10 - 15 - 1 - 1 - 1 - 1 - 1 - 4 5021 - 8 L RO Ouzecchino, 100 - 450.1 - Bala - 6.6603 - R.I. RO 3421 - M. RO 001381 - Cap. Soc. € 1.032.000,00 info@zhermack.com - www.zhermack.com ITALY - GERMANY - POLAND - UNITED STATES - UNITED KINGDOM - RUSSIA - CHINA