PIT AND FISSURE CHEMICAL CURING SEALANT

{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 caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and health. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and is evenly spaced around the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG - 7 2001 Mr. Cesar E. Veliz Official Correspondent Rite-Dent Manufacturing Corporation 1056 East 33rd Street Hialeah, Florida 33013-3526 Re : K011822 Pit and Fissure Chemical Curing Trade/Device Name: Sealant K872.3765 Requlation Number: Requlatory Class: II Product Code: EBC Dated: June 7, 2001 Received: June 11, 2001 Dear Mr. Veliz: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the market the action ially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate use beated in the chiriterstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to ene emat 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 The general controls controls provisions of the Act. provisions of the Act include requirements for annual provisions 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. {1}------------------------------------------------ Page 2 - Mr. Veliz concerning your device in the Eederal Register. Please note: concerning your device in executive submission submission does this response co your premains of the have under sections 531 not arrect any obrigation for may and retres under the Electronic through 542 of the Act 101 actions or other Federal laws or regulations. This letter will allow you to begin marketing your device as Ints recei (x) premarket notification. The FDA described in your 510(x) premaince of your device to a legally marketed predicate device results in a classification for your marketed predicate device robated to proceed to the market. If you desire specific advice for your device on our labeling II you desire specific additionally 809.10 for in regulation (21 ork razes), please contact the Office of Villo dragnoscic devices/// For questionally, for questions on Compliance at (3017-394-1032 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" (21CFR 807.97). J Other general premarket nocification - (arch soies under the Act may be obtained from the Division of Small Manufacturers obtained from the Bivibron assistance at its toll-free number International and combaments - 115577 or at its internet address ('000') <//www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ K011822 August 2, 2001 Rite-Dent Mig. Corp. 1056 East 33% Street Hialeah, FL 33013 Establishment # 1064592 ## INDICATIONS FOR USE 510 (K) Number Unknown Device Name: Pit and Fissure Sealant Indications for Use: This is a chemIcally activated sealant that is used to seal the pit ad fissures found in primary and secondary dentition in combination with the acid etching technique. This sealant assures complete cure in deep fissures. Lilitatn (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 50(k) Number_KO114222