IS 40 MICROMOTOR

K042787 · Satelec · EFB · Dec 17, 2004 · Dental

Device Facts

• Record ID: K042787
• Device Name: IS 40 MICROMOTOR
• Applicant: Satelec
• Product Code: EFB · Dental
• Decision Date: Dec 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

The intended use of the IS40 Micromotor is in general dentistry for cutting, shaping, drilling, cleaning, prophylaxis and polishing of teeth by dental professionals.

Device Story

IS 40 Micromotor is an electric dental handpiece motor; compatible with E-type connection contra-angles with internal spray. Used in conjunction with Satelec Cocoon Hygienist (incorporating M6 module) for automatic servo control of motor power and speed. Operates at 1,600 to 40,000 rpm; provides 1.6 Newton/cm torque at 3 A. Operated by dental professionals in clinical settings for tooth preparation and maintenance procedures. Provides mechanical power to attachments for dental cutting, drilling, and polishing.

Clinical Evidence

No clinical data provided; substantial equivalence based on technical comparison to predicate device.

Technological Characteristics

Electric motor-driven dental handpiece; E-type connection; internal spray compatibility. Speed range: 1,600–40,000 rpm. Torque: 1.6 N/cm at 3 A. Integrated with M6 module for automatic servo control.

Indications for Use

Indicated for use by dental professionals for cutting, shaping, drilling, cleaning, prophylaxis, and polishing of teeth in general dentistry.

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.

Predicate Devices

• eStylus Electric Motor System (K031145)

Reference Devices

• Satelec Cocoon Hygienist (K040529)

Submission Summary (Full Text)

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K042787

## DEC 17 2004

#### 8. SMDA Summary of Safety and Effectiveness - "510(k) Summary"

#### A. Submitter Information

SATELEC Z.I. du Phare, BP 216 Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE

Telephone: [phone] Fax: [phone]

- Steve Salesky Contact Person: SATELEC c/o Acteon, Inc. 130 Gaither Drive, Suite 100 Mt. Laurel, NJ 08054 Telephone: [phone] Fax: [phone]
October 4, 2004 Date Prepared:

B. Device Identification

| Common Usual Name: | Micromotor |
|--------------------|------------------|
| Proprietary Name: | IS 40 Micromotor |

#### C. Identification of predicate Device

The Satelec IS 40 Micromotor is substantially equivalent to the predicate device by Dentsply International, the eStylus™ Electric Motor System (K031145) previously cleared by the FDA and currently marketed.

#### D. Device Description

The IS 40 Micromotor with internal spray is compatible with all types of contra-angles that have an E-type connection and internal spray. The IS 40 Micromotor is used with Satelec Cocoon® Hygienist (K040529) which incorporates the M6 module with automatic servo control for motor power and speed control. IS 40 Micromotor operates at a speed from 1,600 to 40,000 rpm and provides a torque of 1.6 Newton/cm at 3 A.

The intended use is in general dentistry for cutting, shaping, drilling, cleaning, prophylaxis and polishing of teeth by dental professionals.

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### E. Substantial Equivalence

The IS 40 Micromotor and the predicate device, eStylus™ Electric Motor System, are both electric motor driven dental handpieces for use with various attachments intended for use in general dentistry. Differences that exist between the devices relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the IS 40 Micromotor.

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Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2004

SATELEC C/O Mr. Steve Salesky Acteon, Incorporated 130 Gaither Drive, Suite 100 Mt. Laurel, New Jersey 08054

Re: K042787

Trade/Device Name: IS 40 Micromotor Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: October 4, 2004 Received: October 6, 2004

Dear Mr. Salesky:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2 - Mr. Salesky

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Ruane

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K042787

Device Name: IS 40 Micromotor

Indications for Use:

The intended use of the IS40 Micromotor is in general dentistry for cutting, shaping, drilling, cleaning, prophylaxis and polishing of teeth by dental professionals.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suza Quare

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Anesthol. Dental Devices

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510(k) Number. K042787