ROTARY MASTER

K992648 · J. Morita USA, Inc. · EBW · Jan 31, 2000 · Dental

Device Facts

• Record ID: K992648
• Device Name: ROTARY MASTER
• Applicant: J. Morita USA, Inc.
• Product Code: EBW · Dental
• Decision Date: Jan 31, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The ROTARY MASTER device is a control unit that drives a dc electric micromotor that can be turned on or off by a foot switch. It is intended for use in general dental applications such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay, or filling, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle, or contra-angle ISO E-type attachment of equal 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

Rotary Master is a dental control unit driving a DC electric micromotor; operated via foot switch. Speed adjustable (2,000–30,000 rpm) via front-panel control knob. Compatible with straight, right-angle, or contra-angle ISO E-type attachments. Used by dental professionals in clinical settings for tooth preparation, finishing, polishing, and endodontic procedures. Device requires plastic sleeving for infection control as the motor/cord are not autoclavable. Output is mechanical rotation for dental burs/instruments; assists clinicians in precise dental tissue removal and restoration finishing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Control unit for DC electric micromotor; speed range 2,000–30,000 rpm; ISO E-type attachment interface; foot switch control; non-autoclavable motor/cord requiring protective sleeving.

Indications for Use

Indicated for general dental applications including tooth cutting for crown/cavity preparation, finishing of crowns, inlays, or fillings, polishing, prophylaxis, and endodontic treatment. Intended for use 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)

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine, with a single snake winding around a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 31 2000

Keith A. Barritt, Esquire Fish & Richardson, P.C. 601 Thirteenth Street N.W. Washington, D.C. 20005

K992648 Re: Rotary Master Trade Name: Requlatory Class: I Product Code: EBW November 8, 1999 Dated: Received: November 10, 1999

Dear Mr. Barritt:

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. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlatory 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

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Page 2 - Mr. Barritt

obliqation 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 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,

Timothy A. Ulatowski
Director

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): ____________________________________________________________________________________________________________________________________________________

Device Name: ROTARY MASTER

Indications For Use:

510(k) Number _

The ROTARY MASTER device is a control unit that drives a dc electric micromotor that can be turned on or off by a foot switch. It is intended for use in general dental applications such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay, or filling, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle, or contra-angle ISO E-type attachment of equal 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: Because the electric motor and its cord are not autoclavable, an adequate covering by plastic sleeving as commonly used in dentistry for infection control should be used during treatment.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|----------------------|
| (Per 21 CFR 801.109) | | |

| (Division Sign-Off) | 6 |
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| Division of Dental, Infection Control, and General Hospital Devices | |

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