(79 days)
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No
The description details a simple control unit for a dental micromotor with manual speed adjustment, and there is no mention of AI/ML terms or functionalities.
Yes
The device is used in various dental procedures such as cutting, finishing, polishing, prophylaxis, and endodontic treatment, which are therapeutic interventions.
No
Explanation: The device is described as a control unit for a dental micromotor used for various dental procedures such as cutting, polishing, and endodontic treatment. Its function is to drive a motor and adjust its speed, not to diagnose a condition.
No
The device description clearly states it is a "control unit that drives a dc electric micromotor" and includes a "foot switch" and "control knob," indicating it is a hardware device with physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a control unit for a dental micromotor used for mechanical procedures like cutting, finishing, polishing, and endodontic treatment. These are physical manipulations of the tooth and surrounding structures.
- Device Description: The description focuses on the mechanical function of driving a motor and controlling its speed.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings for analyzing biological samples.
Therefore, this device falls under the category of a general dental instrument used for mechanical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is a control unit that drives a dc electric micromotor and turns on or off the motor by its foot switch. It is intended for use in general dental applications for work such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle or contra-angle ISO E-type attachment of equal speed, speed increasing or decreasing sheath. The micromotor speed is adjustable by the control knob on the front face of the control unit from 2,000 to 30,000 rpm.
Product codes
EBW
Device Description
The device is a control unit that drives a dc electric micromotor and turns on or off the motor by its foot switch. The micromotor speed is adjustable by the control knob on the front face of the control unit from 2,000 to 30,000 rpm. The electric motor and its cord are not autoclavable; therefore, an adequate covering by plastic sleeving as commonly used in dental for infection control method should be used during treatment.
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
general dental applications
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 9 1999
Mr. Hiroji Sekiguchi Marketing Manager, North America Official Correspondent NAKANISHI Incorporated 340 Kamihinata, Kanuma-Shi Tochiqi-Ken 322-8666, Japan
Re : K990954 Trade Name: Elec-Mate, Models Ex-6 Set, Ex-6L Set, Ex-30 Set Regulatory Class: I Product Code: EBW Dated: March 19, 1999 March 22, 1999 Received:
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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal_Register.
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Page 2 - Mr. Sekiguchi
Please note: this response to your premarket notification submission does not affect any 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 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 ene office or comprand, "Misbranding by reference to Other qeneral premarket notification" (21 CFR 807.97). 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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510(k) Number (if known): K 99 095
Elec-Mate Device Name:
Indications For Use:
The device is a control unit that drives a dc electric micromotor and turns on or off the motor by its foot switch. It is intended for use in general dental applications for work such as cutting a tooth for crown preparation, cavity preparation, finishing the crown, inlay or the filling, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle or contra-angle ISO E-type attachment of equal speed, speed increasing or decreasing sheath. The micromotor speed is adjustable by the control knob on the front face of the control unit from 2,000 to 30,000 rpm.
Special Note:
The electric motor and its cord are not autoclavable: therefore, an adequate covering by plastic sleeving as commonly used in dental for infection control method should be used during treatment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Coucurrence of CDRH, Office of Device Evaluation (ODE)
Susan Dunne
(Division Sign-Off) Division of Dental, Infection C and General Hos 510(k) Number
Prescription Use
(Per 21 CFR 801.109) √
OR
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Over-The-Counter Use
(Optional Formal 1-2