(83 days)
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No
The summary describes a mechanical handpiece for dental procedures and contains no mention of AI, ML, image processing, or data analysis typically associated with AI/ML devices.
No
The device is used for mechanical actions (cut, shape, grind, polish) on teeth and dental devices, not for treating a disease or condition. It is a dental tool, not a therapeutic device in the medical sense.
No
The device description indicates it is a handpiece used for cutting, shaping, grinding, and polishing teeth or related items, which are treatment rather than diagnostic functions.
No
The device description explicitly states "Microtech Push Button Handpiece," which is a physical hardware component used in dentistry. The intended use also describes physical actions like cutting, shaping, grinding, and polishing, which are performed by a hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a handpiece used for cutting, shaping, grinding, and polishing teeth and related items. This is a mechanical function performed directly on or in the mouth, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing diagnostic information based on sample analysis.
Therefore, this device falls under the category of a dental instrument used for direct treatment and manipulation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This handpiece is to be used for intra and extra orally to cut, shape, grind and polish teeth, or items related to teeth and dental devices that may be in the mouth or to be placed in the mouth.
Product codes
EFB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
intra and extra orally (teeth)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human figures or profiles facing to the right, stacked on top of each other. The figures are depicted in a simple, black and white design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 - . .
OCT 22 2002
MICROTECH
C/O Ms. Grace Holland Regulatory Specialists, Incorporated 3722 Avenue Sausalito Irvine, California 92606
Re: K022535
Trade/Device Name: Microtech Push Button Handpiece Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: July 25, 2002 Received: July 31, 2002
Dear Ms. Holland:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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Page 2 - Ms. Holland
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613 . 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours
Timothy A. Ulatowski
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_1_ of _1
| Indications for Use Statement | |
|---|---|
| 510(k) Number (if known): | R022535 |
Device Name: Microtech Push Button Handpiece
Indications For Use:
This handpiece is to be used for intra and extra orally to cut, shape, grind and polish teeth, or items related to teeth and dental devices that may be in the mouth or to be placed in the mouth.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-The-Counter Use | ||
|---|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
Susan Runne
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | 10000535 |
|---|---|
| ---------------- | ---------- |