PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE

K990646 · Nsk Nakanishi, Inc. · EKX · Mar 19, 1999 · Dental

Device Facts

• Record ID: K990646
• Device Name: PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE
• Applicant: Nsk Nakanishi, Inc.
• Product Code: EKX · Dental
• Decision Date: Mar 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The device is a dc electric micromotor driven by the battery power pack control device with emphasis in mobility to visit schools, nursing homes, house calls, and for emergency need . It is intended for use in general dental applications for light work such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, polishing, and endodontic treatment, with use of straight, right-angle or contra-angle ISO E-type attachment.

Device Story

Handy-Mate is a portable, battery-powered DC electric micromotor system for dental procedures. Designed for mobile dentistry (schools, nursing homes, house calls, emergency care). System consists of a battery power pack and motor handpiece. Compatible with standard ISO E-type attachments (straight, right-angle, contra-angle). Operator (dentist) uses device to perform light dental work: tooth cutting, cavity preparation, finishing, polishing, and endodontic treatment. Device requires plastic sleeving for infection control as motor/cord are not autoclavable.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

DC electric micromotor; battery-powered; portable form factor; compatible with ISO E-type handpiece attachments; non-autoclavable motor/cord requiring plastic sleeving for infection control.

Indications for Use

Indicated for general dental applications including tooth cutting for crown/cavity preparation, finishing, polishing, and endodontic treatment. Suitable for mobile dental environments including schools, nursing homes, house calls, and emergency settings.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 1999

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

Re : K990646 Portable Electric Motor-Handpiece Unit, Trade Name: Handy-Mate Requlatory Class: I Product Code: EKX Dated: February 26, 1999 Received: March 1, 1999

Dear Mr. Sekiguchi

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, Druq, 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ 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 requlation 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 described in your sit in provilence 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 requlation entitled, "Misbranding by reference to ene regaración choroun" (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.fqa.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy 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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510(k) Number (if known): K 990

HANDY-MATE Device Name:

Indications For Use:

The device is a dc electric micromotor driven by the battery power pack control device with emphasis in mobility to visit schools, nursing homes, house calls, and for emergency need .

It is intended for use in general dental applications for light work such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, polishing, and endodontic treatment, with use of straight, right-angle or contra-angle ISO E-type attachment.

Special Note:

The electric motor and its cord are not autoclavable: therefore, an adequate covering by plastic sleeving as commonly used in dental for infection control method is necessary.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)