I-TEC PORTABLE DENTAL OPERATORY

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## MAY 2 1 2004 Mr. Jesse Saint Indigenous People Technology and Education Center 10575 SW 147th Circle Dunnellon, Florida 34432 Re: K040153 . Trade/Device Name: PORTABLE Dental HANDPIECE Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: May 17, 2004 Received: May 17, 2004 Dear Mr. Saint: 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 approvisions of the Act. The general controls provisions of the Act include controls provisions as as annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (sce above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Fxisting major regulations affecting (1 Wr ), it hay of our be code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Ecderal Register. {1}------------------------------------------------ Page 2-Mr. Saint Please be advised that FDA's issuance of a substantial equivalence determination does not I foase be advised that 122 a determination that your device complies with other requirements modi that I Dri has mass statutes and regulations administered by other Federal agencies. of the For of any I ederal stakes requirements, including, but not limited to: registration r od indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 CFR Part 807), and in systems (QS) regulation (21 CFR Part 820); and if requirements as bet form in active 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 This letter will and w Jours reagers in 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 (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 maj obtain 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/dsma/dsmamain.html Sincerely yours, 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}------------------------------------------------ ## Indications for Use 510(k) Number: K040153 Device Name: PORTABLE DENTAL HANDPIECE Indications for Use: The PORTABLE DENTAL HANDPIECE device is a control unit that drives a DC The I ON I ADDE DENTRE FEAT IS in the research on or off by a foot switch. It is intended for elective microniotor that can cons such as cutting a tooth for crown preparation and use in general demar appion, inlay or filling finishing, polishing and endodontic treatment, with use of a contra-angle Doriot Style attachment of equal speed. The treatment, what ass of djustable by the control panel on the top of the control unit from 1,000 to 25,000 rpm. Prescription Use _x_ (Part 21 CFR 801 Subpart D) and/or Over-The-Counter Use (21 CFR 807 Subpart C) ## (DO NOT WRITE BELOW THIS LINE) Concurrence of CDRH, Office of Device Evaluation (ODE) Susa Renser (Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices 510(k) Number:_