COLORBITE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are stacked on one line. The text appears to be extracted from a document or sign. Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement. The seal is black and white. 2006 MAR J Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 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: K053619 Trade/Device Name: Colorbite Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: December 27, 2005 Received: December 27, 2005 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 Eederal Register. {1}------------------------------------------------ ## Page 2 - Mr. Gerald W. 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 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/industry/support/index.html. Sincerely yours. Susan Lyons 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 shows the logo for "Zhermack The Masters in Dentistry". The logo consists of a black square with two white lines inside, followed by the word "Zhermack" in bold black letters. Below the word "Zhermack" is the phrase "The Masters in Dentistry" in a smaller, cursive font. Image /page/2/Picture/1 description: The image contains three logos. The first logo is an octagon with the letters "TUV" in the center, and the text "ISO 9001" and "ISO 13485" on the bottom corners. The second logo is an octagon with the letters "TUV" in the center, and the text "ISO 14001" on the bottom. The third logo is the FDA logo with the text "U.S. Food and Drug Administration Reg No 902780" below it. ## INDICATIONS FOR USE 2 175 3619 510(k) Number (if known): _ Device Name: COLORBITE Indications for Use: Zhermack COLORBITE is a dental impression material indications Tor 650. of a patient's teeth. Prescription Use AND/OR 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 NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 Susan Pearson Shippings, General Huspisci, met. Dental Dovices KC5 3619 COLORBITE Rev. 0 Julyl, 01 2005