(84 days)
An electrically-powered, low-speed (<5000 RPM) demal handpiece as defined in C.F.R. 872.4200 intended for use with a disposable contra-angle device which a suitable rubber cup, or similar for the purpose of cleaning and/or polishing teeth with an appropriate mixture of pumice and water, prophylaxis paste, or the like.
The MODEL MS-1 HANDPIECE is an electrically-powered, lowspeed handpiece intended for use with a contra-angle in which a rubber cup or bristle brush is inserted for the purpose of cleaning and/or polishing teeth using an appropriate prophylaxis paste, pumice/water mixture, or the like.
This document describes a 510(k) submission for a dental handpiece, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and AI/ML-specific metrics cannot be extracted from the provided text.
The document primarily focuses on:
- Device Identification: Trade Name (MODEL MS-1 HANDPIECE), Common Name (Low-Speed Prophy Handpiece), Classification Name (Dental Handpiece).
- Intended Use: An electrically-powered, low-speed handpiece for cleaning and polishing teeth with a contra-angle, rubber cup/bristle brush, and prophylaxis paste.
- Equivalence: Listing of predicate devices, implying a substantial equivalence pathway for clearance rather than a novel technology requiring extensive performance studies.
- Regulatory Clearance: A letter from the FDA indicating that the device has been found substantially equivalent to legally marketed predicate devices.
There is no mention of:
- Acceptance criteria in terms of analytical or clinical performance metrics.
- Specific studies proving performance against such criteria.
- Sample sizes, data provenance, ground truth establishment, expert involvement, or AI/ML-specific study designs (like MRMC or standalone performance).
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Ka83413
DEC 2 1 1998
510(k) SUMMARY
Submitter: Parkell Products Inc. 155 Schmitt Blvd. Box 376 Farmingdale, NY 11735 TEL: 516-249-1134 FAX: 516-249-1242 Nelson J. Gendusa, DDS Contact: Director of Research Parkell 155 Schmitt Blvd. Box 376 Farmingdale, NY 11735 Submission Date: September 24, 1998 MODEL MS-1 HANDPIECE Trade Name: Low-Speed Prophy Handpiece Common Name: Classification Name: Dental Handpiece (C.F.R. §872.4200) Equivalence: Tri-Auto ZX, Periotest, Prophy Champ Handpiece, Robin Cordless Handpiece, M-3 Torx Handpiece and Yoshida Rido-F, Model LM-01. Description/Intended Use: The MODEL MS-1 HANDPIECE is an electrically-powered, lowspeed handpiece intended for use with a contra-angle in which a rubber cup or bristle brush is inserted for the purpose of cleaning and/or polishing teeth using an appropriate prophylaxis paste, pumice/water mixture, or the like.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle with three wavy lines representing its feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 1998
Nelson J. Gendusa, D.D.S. Parkell Products, Incorporated 155 Schmitt Boulevard Box 376 Farmingdale, New York 11735
K983413 Re : Model MS-1 HANDPIECE Trade Name: Requlatory Class: I Product Code: EKX September 24, 1998 Dated: Received: September 28, 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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ 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. Dendusa
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 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 requlation (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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral 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/dsma/dsmama1m.html." .
Sincerely yours
Timothy A. Ulatowski
Timot A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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198 5413 10(k Number (if known):
のお気になる。
Device Name: _MODEL MS-1 HANDPIECE
Indications for Use: An electrically-powered, low-speed (<5000 RPM) demal handpiece as defined in C.F.R. 872.4200 intended for use with a disposable contra-angle device which a suitable rubber cup, or similar for the purpose of cleaning and/or polishing teeth with an appropriate mixture of pumice and water, prophylaxis paste, or the like.
Susan Penn
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices વ્યુહ્ 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.