PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)

K990682 · Nsk Nakanishi, Inc. · EKX · Mar 24, 1999 · Dental

Device Facts

• Record ID: K990682
• Device Name: PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)
• Applicant: Nsk Nakanishi, Inc.
• Product Code: EKX · Dental
• Decision Date: Mar 24, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

This device, a small, battery-powered, light-weight, low-speed electric motor handpiece, runs at 200 rpm to 2000 rpm, and is intended for use in light general dental, prophylaxis, or endodontic works, where low speed is required.

Device Story

Prophy-Mate is a battery-powered, lightweight, low-speed electric motor handpiece for dental use. Operates between 200 and 2000 rpm. Features detachable heads including prophy heads (for screw-in/snap-on cups and brushes), latch heads (for reamers/files), 1/4-turn heads, up-down heads, and 10:1 reduction speed heads. Used by dental professionals in clinical settings for general dental, prophylaxis, and endodontic tasks. Device provides mechanical rotation to attached dental instruments to facilitate clinical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Battery-powered electric motor handpiece; speed range 200-2000 rpm; modular design with various detachable heads (prophy, latch, reduction); manual operation.

Indications for Use

Indicated for light general dental, prophylaxis, or endodontic procedures requiring low-speed operation (200-2000 rpm).

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 1999

Mr. Hiroji Sekiguchi Marketing Manager, N. American Official Correspondent Nakanishi, Incorporated 340 Kamihinata, Kanuma-Shi, Tochigi-Ken 322-8666, JAPAN

Re : K990682 Prophy-Mate Motor Handpiece, Models Prophy-Trade Name: Mate (600 rpm & 2000 rpm) Regulatory Class: I Product Code: EKX Dated: March 2, 1999 March 2, 1999 Received:

Dear Mr. Sekiquchi

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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of

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Page 2 — Mr. Sekiguchi

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Patricia Cucentiffz

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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510(k) Number (if known):

Devicc Namc: PROPHY-MATE Motor Handpiece (6000rpm Max.)

Indications For Use:

This device, a small, battery-powered, light-weight, low-speed electric motor handpiece, runs at 200 rpm to 2000 rpm, and is intended for use in light general dental, prophylaxis, or endodontic works, where low speed is required.

Remarks:

A variety of detachable heads, each of which is pushed into or pulled out of the motor handpiece, are available to perform required job, such as a prophy head for screw-in or snap-on prophy cups and brushes, a latch head for latch reamer or latch file, a 1/4-turn head, up-down head, 10:1 reduction speed head, etc.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Coucurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russo

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K990682

Prescription Use
(Per 21 CFR 801.109) ✓

OR

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Over-The-Counter Use

(Optional Formal 1-2-9