MACH-SIGMA HANDPIECE, ULTRAPUSH

K980162 · Nsk Nakanishi, Inc. · EFB · Jun 5, 1998 · Dental

Device Facts

• Record ID: K980162
• Device Name: MACH-SIGMA HANDPIECE, ULTRAPUSH
• Applicant: Nsk Nakanishi, Inc.
• Product Code: EFB · Dental
• Decision Date: Jun 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The device is intended for use in general dental applications, where high speed cutting is required; such as cutting a tooth for crown preparation, cavity preparation, removing metal crown or fillings. This device uses a USA-patented, long proven check valve, a Non-Retraction Valve, in the water line of the handpiece to prevent the oral fluids, which could be contaminated, from being drawn into the handpiece spray port(s) of the handpiece. The contaminants could reach beyond the handpiece, but this check valve, as being installed in the handpiece body, prevents them from reaching beyond the handpiece.

Device Story

Air-driven dental handpiece; utilizes high-speed rotation for cutting/removing tooth structure or dental restorations. Features integrated non-retraction check valve in water line to prevent backflow of oral fluids into handpiece spray ports; mitigates cross-contamination risk. Operated by dental professionals in clinical settings. Output is mechanical cutting action; provides efficient tooth preparation and restoration removal. Benefits include enhanced infection control via internal valve design and clinical utility in restorative dentistry.

Clinical Evidence

Bench testing only.

Technological Characteristics

Air turbine dental handpiece. Features integrated non-retraction check valve in water line. Powered by compressed air. Form factor is a handheld dental instrument. No software or electronic components.

Indications for Use

Indicated for general dental applications requiring high-speed cutting, including tooth preparation for crowns, cavity preparation, and removal of metal crowns or fillings.

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

5 1998 JUN

Mr. Hiroji Sekiguchi International Division II Manager Official Correspondent Nakanishi, Incorporated 240 Kamihinata, Kanuma-Shi, Tochigi-Ken 322 JAPAN

K980162 Re : Mach-Siqma Handpiece, Ultrapush Trade Name: Requlatory Class: I Product Code: EFB May 26, 1998 Dated: Received: May 29, 1998

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 leqally 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations 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 requirements, 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 requlatory 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 obligation you might have under sections 531

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Page 2 - Mr. Sekiguchi

through 542 of the Act for devices under the Electronic em-ough Sadiation 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 acbeing 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 compriation 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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timotyy 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):

Air Turbine Handpiece, MACH-Sigma (Σ) Ultra-Push Device Name:

Indications For Use:

The device is intended for use in general dental applications, where high speed cutting is required; such as cutting a tooth for crown preparation, cavity preparation, removing metal crown or fillings.

This device uses a USA-patented, long proven check valve, a Non-Retraction Valve, in the water line of the handpiece to prevent the oral fluids, which could be contaminated, from being drawn into the handpiece spray port(s) of the handpiece. The contaminants could reach beyond the handpiece, but this check valve, as being installed in the handpiece body, prevents them from reaching beyond the handpiece.

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

Susan Ruaser

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

Prescription Use (Per 21 CFR 801.109)

OR

## Over-The-Counter Use

(Optional Formal 1-2-96)

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