(83 days)
An air-powered handpiece intended for use in removing dental plaque and stains from teeth by projecting a stream of air, water and sodium bicarbonate onto tooth surfaces. Its use is contraindicated on patients with chronic respiratory disease, renal deficiencies or suffering chronic diarrhea and those on salt-free or salt-limited diet regimens.
Parkell's MODEL MS-2 HANDPIECE is an air-powered handpiece intended for use in removing dental plaque and stains from teeth by projecting a stream of air, water and sodium bicarbonate onto tooth surfaces.
This 510(k) summary describes a dental handpiece, not an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not applicable.
The submission is for the Parkell Model MS-2 Handpiece, an air-powered prophylaxis handpiece intended for removing dental plaque and stains. It is a traditional mechanical device, and its substantial equivalence determination is based on the comparison to a legally marketed predicate device (PROPHYFLEX 2, MODEL 2012), not on clinical performance studies typically associated with AI/ML devices.
The document focuses on the device's intended use, contraindications, and regulatory classification, typical for a 510(k) premarket notification for a Class I mechanical device.
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510(k) SUMMARY
Parkell Products Inc. 155 Schmitt Blvd. Box 376 Farmingdale, NY 11735 TEL: 516-249-1134 FAX: 516-249-1242
Nelson J. Gendusa, DDS Director of Research Parkell 155 Schmitt Blvd. Box 376 Farmingdale, NY 11735
MODEL MS-2 HANDPIECE
Air-Powered, Prophylaxis Handpiece
PROPHYFLEX 2, MODEL 2012.
Handpiece, Air-Powered, Dental (C.F.R. §872.4200)
05 May 1998
Submission Date:
Trade Name:
Common Name:
Classification Name:
Equivalence:
Description/Intended Use:
Parkell's MODEL MS-2 HANDPIECE is an air-powered handpiece intended for use in removing dental plaque and stains from teeth by projecting a stream of air, water and sodium bicarbonate onto tooth surfaces. Its use is contraindicated on patients with chronic respiratory disease, renal deficiencies or suffering chronic diarrhea and those on salt-free or salt-limited diet regimens.
SEP
Submitter:
2 1998
Contact:
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1998 SEP
Nelson J. Gendusa, D.D.S. Director of Research Parkell 155 Schmitt Boulevard P.O. Box 376 Farmingdale, New York 11735
K982050 Re : Trade Name: Model MS-2 Handpiece Requlatory Class: I Product Code: EFB Dated: June 5, 1998 Received: June 11, 1998
Dear Dr. Gendusa:
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 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). 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 aqainst 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 regulations 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 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. 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
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Page 2 - Dr. Gendusa
through 542 of 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 The FDA described in your 510(k) premarket notification. asberizon in your in your device 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" (21CFR 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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
S. Autman for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Page _________________________________________________________________________________________________________________________________________________________________________
510(k Number (if known): _____________________________________________________________________________________________________________________________________________________
Device Name: MODEL MS-2 HANDPECE
An air-powered handpiece intended for use in removing dental plaque and stains from teeth by projecting a Indications for Use: stream of air, water and sodium bicarbonate onto tooth surfaces. Its use is contraindicated on patients with chronic respiratory disease, renal deficiencies or suffering chronic diarrhea and those on salt-free or salt-limited diet regimens.
Susan Runser
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.