(38 days)
Not Found
Unclear
No
The summary describes a mechanical dental turbine and does not mention any software, algorithms, or AI/ML capabilities.
No
The device, an air turbine for dental handpieces, is used for mechanical actions like cutting and drilling teeth for various dental procedures. It does not exert a therapeutic effect on the body; its function is purely instrumental in facilitating the dental treatment.
No
The device is described as an air turbine for dental handpieces used for procedures like cutting teeth and preparing cavities, which are treatment procedures, not diagnostic ones.
No
The device description explicitly states it is an "air turbine," which is a physical component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general dental applications; such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, etc." This describes a mechanical action performed on a patient's tooth, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is an "air turbine" for a dental handpiece. This is a mechanical component used in a dental procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly operates in vivo (within the body) during a dental procedure.
N/A
Intended Use / 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.
Product codes
EFB
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged horizontally, with "Public" and "Health" on the first line and "Service" on the second line. The text appears to be part of a document or sign.
Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, stacked on top of each other.
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
2
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)