(85 days)
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No
The summary describes a standard dental handpiece and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
A "therapeutic device" is typically one that treats or heals. While a dental handpiece is used for procedures that contribute to the treatment of dental issues (like removing caries), its primary function as described is preparatory and restorative, rather than directly therapeutic in the sense of healing disease or injury.
No
The provided "Intended Use / Indications for Use" describes functions that are interventional (removing material, preparing teeth, polishing), not diagnostic. It does not mention identifying diseases or conditions.
No
The device is described as a "dental low-speed handpiece," which is a physical hardware device used in dentistry. The summary does not mention any software component as the primary or sole function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for mechanical procedures directly on the teeth (removing material, preparing cavities, polishing, etc.). This is a therapeutic or surgical application, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue) or to provide information about a patient's health status or disease. IVDs are specifically designed for these purposes.
- Anatomical Site: The device is used on teeth, which are part of the patient's body, not a sample taken from the body.
In summary, the function of a dental low-speed handpiece as described is to physically alter or prepare teeth, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
A dental low-speed handpiece is designed for removing carious material, cavity and crown preparation, excess filling material, root canal preparations, finishing tooth preparations, restorations and polishing teeth.
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
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/10 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three curved lines representing its wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the border of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 2000
Mr. Patrick Ridenour, Manager Enqineering Services A-Dec, Incorporated 2601 Crestview Drive Newberg, Oregon 97132-9257
Re : K993526 Trade Name: Synea - LS Low-Speed Handpiece Requlatory Class: I Product Code: EFB October 11, 1999 Dated: Received: October 18, 1999
Dear Mr. Ridenour:
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 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 Regulations, Title 21, Parts 800 to 895. ਉ 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
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Page 2 - Mr. Ridenour
obligation you might have under sections 531 through 542 of 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 leqally 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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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 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 (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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INDICATIONS FOR USE: ●
- A dental low-speed handpiece is designed for removing carious material, cavity and crown preparation, excess filling material, root canal preparations, finishing tooth preparations, restorations and polishing teeth.
Susan Runner
(Division Sign-Off) (Division Sign-Off)
Division of Dental, Infection Control, Divisioneral Hospital Devices 1000 25260 510(k) Number .
Prescription Use
(Per 21 CFR 801.109)