23:1 REDUCTION ANGLE

K973800 · Midwest Dental Products Corp. · EGS · Mar 11, 1998 · Dental

Device Facts

• Record ID: K973800
• Device Name: 23:1 REDUCTION ANGLE
• Applicant: Midwest Dental Products Corp.
• Product Code: EGS · Dental
• Decision Date: Mar 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Indications for Use of this device is to provide a dental professional a lowspeed handpiece which may be used, in conjunction with various dental burs as identified by the dental professional, in the performance of various dental procedures including, but not limited to, Prophy, Post and Pin Drilling, Pin Setting, Root Canal Enlargement and Sealing, and Caries Removal. The intended patient population is the general population requiring such procedures.

Device Story

The 23:1 Reduction Angle is a low-speed dental handpiece used by dental professionals in clinical settings. It attaches to a dental motor and accepts various dental burs to perform procedures such as prophy, post and pin drilling, pin setting, root canal enlargement, and caries removal. The device functions as a mechanical tool to provide controlled rotation for dental instruments. It is operated by a dentist or dental hygienist to facilitate precise mechanical work on teeth. The output is the mechanical action of the attached bur, which allows the clinician to perform restorative or endodontic tasks. It benefits the patient by enabling efficient and accurate dental treatment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Low-speed dental handpiece with a 23:1 reduction gear ratio. Mechanical device; no energy source or software components. Designed for attachment to standard dental handpiece motors.

Indications for Use

Indicated for general population requiring dental procedures including prophy, post and pin drilling, pin setting, root canal enlargement/sealing, and caries removal. For use by dental professionals.

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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Mr. Robert E. Booth ·Director, Regulatory Affairs/Quality Midwest Dental Products 901 West Oakton Street Des Plaines, Illinois 60018

Re : K973800 23:1 Reduction Angle Trade Name: Regulatory Class: I EGS Product Code: Dated: December 22, 1997 Received: December 29, 1997

Dear Mr. Booth:

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, Druq, 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, qood 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with " the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Booth

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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K973800/A'

Image /page/2/Picture/1 description: The image shows the logo for Dentsply Midwest. The word "DENTSPLY" is in a bold, sans-serif font, with the letters slightly overlapping. Below it, the word "MIDWEST" is in a smaller, italicized, sans-serif font. The logo is in black and white.

Midwest Dental Products Division of DENTSPLY International 901 West Oakton Street Des Plaines, IL 60018-1884 Phone [phone] Fax [phone]

## Statement of Indications for Use

Dental Handpiece; Speed Reduction Angle 510(k) Number: K973800

The Indications for Use of this device is to provide a dental professional a lowspeed handpiece which may be used, in conjunction with various dental burs as identified by the dental professional, in the performance of various dental procedures including, but not limited to, Prophy, Post and Pin Drilling, Pin Setting, Root Canal Enlargement and Sealing, and Caries Removal. The intended patient population is the general population requiring such procedures.

Respectfully Submitted DENTSPLY Midwe

Robert E. Booth Director, Regulatory Affairs/Quality

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Susan Runser

(Division Sign-Off) (Division of Dental. Infection Control, and General Hospital Devices 3800 510(k) Number

Prescription Use (Per 21 CFR 801.109)

SK=69