SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL

{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 stylized image of an eagle with three human profiles embedded within its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 । 1898 MAY Mr. Bernard Van Dujin ·Manager, Technical Services Cavex Holland B.V. Harmenjansweg 19-21 P.O. Box 852 2003 RW Haarlem THE NETHERLANDS K980965 -Re : Spectra Form Chromatic Alginate Impression Trade Name: Material Requlatory Class: II ELW Product Code: Dated: March 13, 1998 Received: March 16, 1998 Dear Mr. Bernard Van Dujin: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major ----requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of {1}------------------------------------------------ Page 2 - Mr. Bernard Van Dujin the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, K. Chilton Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## 510(k) NUMBER (IF KNOWN) : K980965 ## DEVICE NAME: SPECTRA FORM™ Chromatic Alginate Impression Material ## INDICATIONS FOR USE: SPECTRA FORM™ Chromatic Alginate Impression Material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. It is a general purpose impression material for making study models, first impressions for the construction of individual trays, situation models, orthodontic impressions etc. SPECTRA FORM™ Chromatic Alginate Impression Material is a color-changing alginate: it becomes violet upon contact with water in the mixing bowl, changes to pink indicating the end of the mixing time and then finally changes to off-white indicating the end of the setting time in the mouth. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. ) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Over-The-Counter-Use (Optional Format 1-2-96) Sason Kunes (Division Sign-Off) Division of Dental, Infection Control. and General Hospital Device 510(k) Number OR Image /page/2/Picture/12 description: The image is a blank white canvas, devoid of any discernible objects, shapes, or colors. The uniformity of the white background creates a sense of emptiness and simplicity. There are no textures or patterns visible, resulting in a smooth and featureless surface. The image lacks any focal point or visual interest, presenting a minimalist and abstract composition. Image /page/2/Picture/13 description: The image contains a solid black circle. The circle is centered in the image and takes up a significant portion of the frame. The edges of the circle are slightly irregular, suggesting it may have been hand-drawn or digitally created with a brush-like tool. There are no other discernible elements or details in the image.