(83 days)
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. In addition to above Indication for Use, we would like to emphasize, as a USA-patented, long proven dust shield mechanism, Clean-Head System, is used as an integral part of the turbine cartridge, that this device is able to substantially reduce bacterial contamination of the handpiece exhaust air lines to the dental unit.
Air Turbine Handpiece, Mach-Sigma Ultra Push
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental handpiece. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. Therefore, I cannot fulfill your request based on the given input.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol of medicine, with a single snake winding around a staff. The caduceus is composed of three wavy lines that form the shape of a snake and staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 10 1999
Mr. Hiroji Sekiguchi Marketing Manager-North America Official Correspondent Nakanishi, Incorporated 340 Kamihinata, Kanuma-Shi, Tochiqi-Ken 322 JAPAN
Re : K991701 Mach-Sigma Handpiece, Ultrapush, Models Trade Name: Mach-Sigma MU (Mini Head) Requlatory Class: I Product Code: EFB Dated: May 17, 1999 Received: May 19, 1999
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 be subject to such additional controls. Existing major regulations 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) 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 regulation 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 xitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance Also, please note the regulation entitled, at (301) 594-4639. "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under 807.97). the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (1800) 638-2041 or (301) 443-6597
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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510(k) Number (if known):_K 9 9 170 (
Device Name: Air Turbine Handpiece, Mach-Sigma Ultra Push
Indications For Use:
The device is intended for use in general dental spplications, where high speed cutting is required. such as cutting a tooth for crown preparation, cavity preparation, removing metal crown or fillings.
In addition to above Indication for Use, we would like to emphasize, as a USA-patented, long proven dust shield mechanism, Clean-Head System, is used as an integral part of the nurbine cartridge, that this device is able to substantially reduce bacterial contamination of the handpiece exhaust air lines to the dental unit.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rummer
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
9
§ 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.