(14 days)
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No
The summary describes a standard dental handpiece and does not mention any AI or ML capabilities.
No.
The primary purpose of a dental handpiece as described is to prepare dental cavities and clean teeth, which are procedural tools rather than devices that directly treat or mitigate a disease or condition. While used in dental care, its function is mechanical preparation, not therapeutic application in the medical sense.
No
A dental handpiece is used for physical preparation of dental cavities and cleaning teeth, which are treatment procedures, not diagnostic activities. It does not analyze patient data or provide information for diagnosis.
No
The device description explicitly states "Dental Handpiece and Accessories," which are physical hardware components used in dentistry.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prepare dental cavities and clean teeth. This is a direct intervention on the patient's body, not an examination of specimens taken from the body.
- Device Description: The device is described as a "Dental Handpiece and Accessories," which falls under the category of dental instruments used for physical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This dental handpiece performs a physical procedure directly on the patient.
N/A
Intended Use / Indications for Use
The dental handpiece is intended to be used by dentists to prepare dental cavities for restorations such as fillings and for cleaning 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
dentists
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
Image /page/0/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or progress. The overall design is simple and professional, reflecting the department's role in public health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 2 1998
D.B.I America Corporation ·C/O Mr. Kent Donohue Staff Engineer Engineering Services Underwriters Laboratories, Incorporated® 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, North Carolina 27709-3995
Re : K981990 MRS-400, MAXI-400, MRSL-400, MAXI-400L Trade Name: Regulatory Class: I Product Code: EFB Dated: June 5, 1998 June 8, 1998 Received:
Dear Mr. Donohue:
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 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). 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 aqainst 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 Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
1
Page 2 - Mr. Donohue
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 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" (21CFR 807.97). Other qeneral 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/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K981G90 510(k) Number (if known):_
Device Name:_ Dental Handpiece and Accessories (21 CFR 872.4200)
Indications For Use:
The dental handpiece is intended to be used by dentists to prepare dental cavities for restorations such as fillings and for cleaning teeth.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Pinar
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number 10981990
Prescription Use (Per 21CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)