(84 days)
Not Found
Not Found
No
The description focuses on a mechanical handpiece for cleaning and polishing teeth and does not mention any AI/ML components or functions.
No.
The device is used for cleaning and polishing teeth, which is a cosmetic and preventative procedure rather than a therapeutic one designed to treat a disease or condition.
No
The device is described as a handpiece used for cleaning and polishing teeth, which are therapeutic and maintenance functions, not diagnostic.
No
The device description clearly states it is an "electrically-powered, low-speed demal handpiece" and a "MODEL MS-1 HANDPIECE," indicating a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cleaning and polishing teeth, which is a procedure performed directly on the patient's body (in vivo).
- Device Description: The description confirms it's a handpiece used for mechanical cleaning and polishing of teeth.
- Lack of IVD Characteristics: There is no mention of analyzing samples taken from the body (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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.
An electrically-powered, low-speed (
§ 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.
0
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.
1
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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Page_1__ I of __
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 (