SERIES XE, SERIES SE, SERIES TE

K971350 · Micro-Mega Societe Anonyme · EGS · Jun 4, 1997 · Dental

Device Facts

• Record ID: K971350
• Device Name: SERIES XE, SERIES SE, SERIES TE
• Applicant: Micro-Mega Societe Anonyme
• Product Code: EGS · Dental
• Decision Date: Jun 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

These contra-angles are intended for use on dental motors equipped with a coupling according to ISO Standard 3964. The speed of the motors may not exceed 40 000 RPM. These contra-angles may receive all dental instruments for contra-angles (burs, prophylaxis instruments, endodontic instruments) whose shank is of type 1, such as determined in ISO Standard 1797. They allow to carry out all low speed dental works. Their usage is of course reserved to dentists or hygienists who are duly graduated and entitled to exercise.

Device Story

Series XE, SE, and TE contra-angles are dental handpieces designed for attachment to dental motors via ISO 3964 couplings. Devices accept type 1 shank instruments (burs, prophylaxis, endodontic) per ISO 1797. Operated by dentists or hygienists in clinical settings for low-speed dental procedures. Maximum motor speed is 40,000 RPM. Devices function as mechanical interfaces to transmit rotational power from the motor to the dental instrument.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical dental handpieces; compatible with ISO 3964 motor couplings and ISO 1797 type 1 instrument shanks. Maximum operational speed 40,000 RPM.

Indications for Use

Indicated for use by graduated dentists or hygienists for low-speed dental procedures, including the use of burs, prophylaxis instruments, and endodontic instruments, when attached to dental motors with ISO 3964 couplings.

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
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN - 4 1997

Ms. Jean-Marie Badoz
MICRO-MEGA SA
5-12 rue du Tunnel
25006 Besancon
FRANCE

Re: K971350
Trade Name: Series XE, Series SE Series TE
Regulatory Class: I
Product Code: EGS
Dated: April 1, 1997
Received: April 10, 1997

Dear Ms. Badoz:

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 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 (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 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

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Page 2 - Ms. Badoz

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 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
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: _________________________

Indications For Use:
CONTRA-ANGLES 04 XE - 06 XE - 08 XE
04 SE - 06 SE - 08 SE
04 TE - 06 TE - 08 TE

These contra-angles are intended for use on dental motors equipped with a coupling according to ISO Standard 3964.

The speed of the motors may not exceed 40 000 RPM.

These contra-angles may receive all dental instruments for contra-angles (burs, prophylaxis instruments, endodontic instruments) whose shank is of type 1, such as determined in ISO Standard 1797.

They allow to carry out all low speed dental works.

Their usage is of course reserved to dentists or hygienists who are duly graduated and entitled to exercise.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Purvey
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number X97B50

Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)