(38 days)
The devices claimed hereis are the air turbines only, and are not the handpiece itself.
The devices are intended for use in the Miwest's Quiet-Air or Tradition handpieces, in place of Midwest's original turbines.
The device, therefore, is, with Midwest handpiece, intended for use in general dental applications; such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, etc.
NSK Pushbutoon Autochuck Replacement Turbine. The devices claimed hereis are the air turbines only, and are not the handpiece itself.
The provided document is a 510(k) clearance letter from the FDA for a dental turbine. It is a regulatory approval document and does not contain information about acceptance criteria or a study proving device performance as would be found in a clinical trial report or a detailed technical submission.
Therefore, I cannot extract the requested information from the provided text. The document confirms that the "NSK Push-Button Midwest Replacement Turbine" is substantially equivalent to legally marketed predicate devices and outlines the indications for use. It does not include data on acceptance criteria, device performance, sample sizes for testing or training, expert qualifications, or ground truth methodologies.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 20 1997
Mr. Hiroji Sekiguchi International Division II Manager Official Correspondent 340 Kamihinata, Kanuma-Shi Tochigi-ken, Japan 322
Re : K971774 NSK Push-Button Midwest Replacement Turbine: Trade Name: For Quietair and Tradition Requlatory Class: I Product Code: EFB Dated: May 12, 1997 Received: May 13, 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, 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 Existing major be subject to such additional controls. 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Sekiguchi
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
W. Waldbush
Timot Ulatowski ay A. 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):
Device Name: NSK Pushbutoon Autochuck Replacement Turbine.
Indications For Use:
The devices claimed hereis are the air turbines only, and are not the handpiece itself.
The devices are intended for use in the Miwest's Quiet-Air or Tradition handpieces, in place of Midwest's original turbines.
The device, therefore, is, with Midwest handpiece, intended for use in general dental applications; such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, etc.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sign-Off) Division of Dental, Intection Control, and General Hospital Devices 510(k) Number _L(
Prescription User (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Formal 1-2-96)
§ 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.