(91 days)
Ax's Endo® handpieces are intended to hold burs or other tools and to transmit power to these via a motor.
Ax's Endo® handpieces are intended to hold burs or other tools and to transmit power to these via a motor.
This is an FDA 510(k) clearance letter for the Ax's Endo® dental handpiece. This document is a regulatory approval, not a scientific study report. Therefore, it does not contain information regarding acceptance criteria for a device's performance based on a study, nor does it describe a study proving the device meets particular criteria.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance. This means the FDA found that the new device is as safe and effective as a legally marketed device that is not subject to PMA.
Therefore, I cannot fulfill your request for the specific points about acceptance criteria and a study from the provided document.
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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 (800) 638-2041 or (301) 443-6597 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:_
Page 1 of __
§ 872.4200 Dental handpiece and accessories.
(a)
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.(b)
Classification. Class I.