RADENT PROPHY PASTE

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN - 9 2004 Mr. Vincent M. Tentarelli Quality Assurance Manager Pascal Company, Incorporated 2929 NE Northup Way Bellevue, Washington 98004 Re: K040661 Trade/Device Name: Radent Prophy Paste Regulation Number: 872.6030 Regulation Name: Oral Cavity Abrasvie polishing Agent Regulatory Class: I Product Code: EJR Dated: March 11, 2004 Received: March 22, 2004 Dear Mr. Tentarelli: We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed young your and have determined the device is substantially equivalent (for the relered above and have and in the enclosure) to legally marketed predicate devices marketed in murcations for ass blaving to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to are rooms Act (Act) that do not require approval of a premarket the Federal F 600; Drag, Drag, therefore, market the device, subject to the general approvin uppliedicon (1 the Act. The general controls provisions of the Act include controls provisions of an 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 (1 writ), it hay of budyer in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Page 2 - Mr. Tentarelli 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 incall that I DIT mas made and regulations administered by other Federal agencies. of the Act of ally I oderal backed as a requirements, including, but not limited to: registration r ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CF Real 807), and 1007), regulation (21 CFR Part 820); and if requirements as set form in the quarily is nontrol 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) This letter will anon yourse bogan finding of substantial equivalence of your device to a premarket notification. - I 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), 11 you desire specific at 130 Compliance at (301) 594-4613. 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 may oveant other gallery, International and Consumer Assistance at its toll-free Drimber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Clu 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}------------------------------------------------ ## V. STATEMENT OF INDICATIONS FOR USE | <strong>Labels</strong> | <strong>Values</strong> | |----------------------------|-------------------------| | 510 (k) NUMBER (IF KNOWN): | K040661 | | DEVICE NAME: | RADENT PROPHY PASTE | INDICATIONS FOR USE: To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment. Susan Russo (Division Sign-C sion Sign-Off, Infection Control, Dental 510(k) Number: (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) OR Over-The-Counter-Use (Optional Format 1-2-96)