E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION

K972569 · Nsk Nakanishi, Inc. · EGS · Oct 8, 1997 · Dental

Device Facts

• Record ID: K972569
• Device Name: E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION
• Applicant: Nsk Nakanishi, Inc.
• Product Code: EGS · Dental
• Decision Date: Oct 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

The device is intended for use where high speed such as 200,000 rpm is required in general dentistry with or without use of coolant; such as cutting a tooth for cavity and/or crown preparation and finishing, cutting and/or finishing of dentures, denture bases, crowns, inlays and metal plates. The device is driven by an electric micromotor or an air motor handpiece that has the ISO-3964 Coupling.

Device Story

E-Type Speed Increaser Contra Angle (ES-95) is a dental handpiece attachment; functions as a mechanical speed increaser. Input: rotational energy from an electric micromotor or air motor handpiece via ISO-3964 coupling. Output: high-speed rotation (up to 200,000 rpm) for dental burs/instruments. Used in clinical dental settings by licensed dentists/dental professionals. Facilitates tooth preparation, crown finishing, and prosthetic adjustment. Benefits patient by enabling precise, efficient removal of tooth structure or restorative materials.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical speed-increasing contra-angle handpiece. Features ISO-3964 coupling for compatibility with standard electric or air micromotors. Operates via mechanical gear transmission to achieve 200,000 rpm output. Designed for general dental use with or without coolant.

Indications for Use

Indicated for general dentistry procedures requiring high-speed rotation (up to 200,000 rpm), including cavity preparation, crown preparation, finishing, and the cutting/finishing of dental prosthetics (dentures, inlays, metal plates). No specific patient population or contraindications listed.

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 20856

OCT - 8 1997

Mr. Hiroji Sekiguchi Official Correspondent NSK Nakanishi, Incorporated 340 Kamihinata, Kanuma-Shi Tochigi-Ken 322 Japan

Re : K972569 E-Type Speed Increaser Contra Angle, ES-95 Trade Name: Regulatory Class: I Product Code: EGS Dated: July 8, 1997 Received: July 10. 1997

Dear Mr. Sekiguchi:

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 reqistration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst 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. ਸੇ 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. Sekiquchi

through 542 of the Act for devices under the Electronic enroagn sadiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acborized in your alence 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.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timot A Directdr 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):

E-TYPE SPEED INCREASER CONTRA ANGLE, ES-95 Device Name:

Indications For Use:

The device is intended for use where high speed such as 200,000 rpm is required in general dentistry with or without use of coolant; such as cutting a tooth for cavity and/or crown preparation and finishing, cutting and/or finishing of dentures, denture bases, crowns, inlays and metal plates.

The device is driven by an electric micromotor or an air motor handpiece that has the ISO-3964 Coupling.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

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

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Formal 1-2-96)