ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET

K990954 · Nsk Nakanishi, Inc. · EBW · Jun 9, 1999 · Dental

Device Facts

• Record ID: K990954
• Device Name: ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET
• Applicant: Nsk Nakanishi, Inc.
• Product Code: EBW · Dental
• Decision Date: Jun 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The device is a control unit that drives a dc electric micromotor and turns on or off the motor by its foot switch. It is intended for use in general dental applications for work such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle or contra-angle ISO E-type attachment of equal speed, speed increasing or decreasing sheath. The micromotor speed is adjustable by the control knob on the front face of the control unit from 2,000 to 30,000 rpm.

Device Story

Elec-Mate is a dental control unit driving a DC electric micromotor; operated via foot switch. Input: manual speed adjustment via front control knob (2,000–30,000 rpm). Output: rotational power to ISO E-type attachments (straight, right-angle, contra-angle) for dental procedures. Used in dental clinics by dental professionals. Device requires plastic sleeving for infection control as motor/cord are not autoclavable. Benefits: provides adjustable, controlled power for various dental restorative and endodontic tasks.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Control unit for DC electric micromotor; speed range 2,000–30,000 rpm; compatible with ISO E-type attachments; non-autoclavable motor/cord requiring plastic sleeving; electrical energy source.

Indications for Use

Indicated for general dental applications including tooth cutting for crown/cavity preparation, finishing, polishing, prophylaxis, and endodontic treatment. Used with ISO E-type attachments.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 9 1999

Mr. Hiroji Sekiguchi Marketing Manager, North America Official Correspondent NAKANISHI Incorporated 340 Kamihinata, Kanuma-Shi Tochiqi-Ken 322-8666, Japan

Re : K990954 Trade Name: Elec-Mate, Models Ex-6 Set, Ex-6L Set, Ex-30 Set Regulatory Class: I Product Code: EBW Dated: March 19, 1999 March 22, 1999 Received:

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, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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.

{1}------------------------------------------------

Page 2 - Mr. Sekiguchi

Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 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 regulation (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 ene office or comprand, "Misbranding by reference to Other qeneral premarket notification" (21 CFR 807.97). 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,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number (if known): K 99 095

Elec-Mate Device Name:

Indications For Use:

The device is a control unit that drives a dc electric micromotor and turns on or off the motor by its foot switch. It is intended for use in general dental applications for work such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle or contra-angle ISO E-type attachment of equal speed, speed increasing or decreasing sheath. The micromotor speed is adjustable by the control knob on the front face of the control unit from 2,000 to 30,000 rpm.

## 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 should be used during treatment.

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

Coucurrence of CDRH, Office of Device Evaluation (ODE)

Susan Dunne

(Division Sign-Off) Division of Dental, Infection C and General Hos 510(k) Number

Prescription Use
(Per 21 CFR 801.109) √

OR

4

Over-The-Counter Use

(Optional Formal 1-2