ENDO-EZE MOTOR AND HANDPIECE

K992380 · Ultradent Products, Inc. · EFB · Oct 13, 1999 · Dental

Device Facts

• Record ID: K992380
• Device Name: ENDO-EZE MOTOR AND HANDPIECE
• Applicant: Ultradent Products, Inc.
• Product Code: EFB · Dental
• Decision Date: Oct 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Endo-Eze 965A UL Contra-Angle Handpiece is designed to be used with the Endo-Eze Shaping Files and all other files with handle diameters up to 2.35 mm. The Endo-Eze A25 UL Air Motor and Handpiece is a mechanical device to be used by dentists performing root canal treatment.

Device Story

The Endo-Eze Motor and Handpiece is a mechanical dental instrument used by dentists during root canal procedures. The system consists of an air-driven motor and a contra-angle handpiece designed to hold and rotate endodontic shaping files. The device functions by providing mechanical rotation to the files, which the clinician uses to shape and clean root canals. It is intended for use in a clinical dental setting. The device assists the practitioner in performing endodontic therapy by automating the rotation of the file, potentially improving efficiency and consistency in canal preparation compared to manual instrumentation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical air-driven motor and contra-angle handpiece. Designed for compatibility with standard endodontic files up to 2.35 mm diameter. Operates via pneumatic power source. Class I medical device.

Indications for Use

Indicated for use by dentists performing root canal treatment using Endo-Eze Shaping Files or compatible files with handle diameters up to 2.35 mm.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 3 1999

Mr. Scott E. Moore Regulatory Affairs Manager Ultradent Products Incorporated 505 West 10200 South South Jordan, Utah 84095

Re : K992380 Trade Name: Endo-Eze Motor and Handpiece Requlatory Class: I Product Code: EFB Dated: July 6, 1999 Received: July 16, 1999

Dear Mr. Moore:

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 Regulations, Title 21, Parts 800 to 895. A 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 regulatory 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. Moore

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,

Susan Turner

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): Unknown

Endo-Eze Motor and Handpiece Device Name: ____

Indications For Use:

The Endo-Eze 965A UL Contra-Angle Handpiece is designed to be used with the Endo-Eze Shaping Files and all other files with handle diameters up to 2.35 mm. The Endo-Eze A25 UL Air Motor and Handpiece is a mechanical device to be used by dentists performing root canal treatment.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-9

Sinahym

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number