AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232

K042171 · Micro-Mega Societe Anonyme · EGS · Nov 10, 2004 · Dental

Device Facts

• Record ID: K042171
• Device Name: AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232
• Applicant: Micro-Mega Societe Anonyme
• Product Code: EGS · Dental
• Decision Date: Nov 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Ax's Endo® handpieces are intended to hold burs or other tools and to transmit power to these via a motor.

Device Story

Ax's Endo® is a dental handpiece; functions to hold burs or other tools; transmits power from a motor to the tool. Used by dental professionals in clinical settings for dental procedures. Device facilitates mechanical action required for dental work; benefits patient by enabling standard dental treatments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental handpiece; mechanical tool holder; motor-driven; Class I device per 21 CFR 872.4200; Product Code EGS.

Indications for Use

Indicated for use as a dental handpiece to hold burs or other tools and transmit power from a motor for dental procedures.

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 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 an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 0 2004

Mr. Philippe Garcia Director, Quality and Regulatory Affairs Micro-Mega Societe Anonyme 5-12 Rue du Tunnel -BP 1353 Cedex Besancon 25006 FRANCE

Re: K042171

Trade/Device Names: Ax's Endo® Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: July 30, 2004 Received: September 02, 2004

Dear Mr. Garcia:

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. Philippe Garcia

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that IDA s Issualled of a sacerian complies with other requirements of the Act or that FDA has made a decemination that your ced by other Federal agencies. You must comply with (1) CEP Beach C any Federal statures and regulations administered of to: registration and listing (21 CFR Part 817); all the Act s requirements, morading, bactice requirements as set forth in the quality labeling (21 CFR Part 001), good manager of any of applicable, the electronic product radiation systems (QB) regarders (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) I mis letter wili anow you to begin mancellig of substantial equivalence of your device to a legally premarket notification: "The PDF mainly of bation 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 If you desire specific advice for your ac no november 10-1. Also, please note the regulation entitled, Contact the Office of Compulation and et notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general internation on your responsibilities at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Clive S. Lewis, Ph.D.

Chiu S. Lin, PhD 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): K042171

Device Name: Ax's Endo® Indications for Use:

Ax's Endo® handpieces are intended to hold burs or other tools and to transmit
ed to the success that the saving a motor AX s Endo® handpost to these via a motor.

Prescription Use _ × (21 CFR Part 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR Part 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russ

K64217

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Division of Ancolnoontoontal Devices

510(k) Number:_

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