(83 days)
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No
The description focuses on basic electrical and mechanical control of a dental handpiece motor speed via a foot pedal, with no mention of AI or ML terms or functionalities.
No
The device is described as a "control unit" for a dental handpiece, regulating its speed and power. It does not directly provide therapy but rather controls a tool that performs dental procedures.
No
The device is described as a control unit for dental handpieces, regulating motor speed for various dental procedures. It does not mention any function related to diagnosing medical conditions or diseases.
No
The device description explicitly states it is a "control unit" connected to physical components like an AC power supply, handpiece hose, and foot control, indicating it is a hardware device with integrated control functions, not a standalone software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a control unit for a dental handpiece. Its function is to control the speed and operation of a motor used for various dental procedures performed directly on the patient's teeth and mouth.
- Intended Use: The intended use describes procedures like crown preparation, cavity preparation, polishing, etc., all of which are performed directly on the patient.
- No Mention of Samples: There is no mention of the device being used to analyze samples taken from the body.
Therefore, this device falls under the category of a medical device used for direct patient treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is a control unit, which is connected to an ac power supply and a handpiece hose, that r rie do roo is a control and turns on or off or regulates the speed of the motor by the foot antrol of the dental unit. It has a provision for a low voltage dc power supply for the handpiece with light. It is intended as a control unit for the handpiece used in general dental applications for while it is to intended woth for crown preparation, cavity preparation, finishing the crown, inlay wothe filling, polishing, prophylaxis and endodontic treatment, with use of straight, right- and or the fining, ponsibiling, provithout internal coolant, of equal, step-up, or stepdown speed sheath. The maximum free speed of the electric micromotor is 40,000 rpm.
Product codes
EBW
Device Description
The device is a control unit, which is connected to an ac power supply and a handpiece hose, that serves as a control for a micromotor by means of a foot control, regulating the speed and turning it on or off. It also provides a low voltage DC power supply for a handpiece with light.
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
Dental professionals in a general dental application setting.
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)
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Reference Device(s)
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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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring three abstract, curved shapes that resemble human profiles or flowing ribbons.
SEP 1 1 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Hiroji Sekiguchi Manager and Official Correspondent Nakanishi. Incorporated 340 Kamihinata, Kanuma-Shi Tochigi-Ken, JAPAN
Re: K011926
Trade/Device Name: Elect-Mate E Regulation Number: 872.4200 Regulation Name: Electric Control Unit with Micromotor Regulatory Class: I Product Code: EBW Dated: June 18, 2001 Received: June 20, 2001
Dear Mr. Sekiguchi:
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 vour 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
1
Page 2 - Mr. Sekiguchi
of the Act or any Federal statutes and regulations administered by other Federal agencies. 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 (section 531-542 of the Act; 21): CFR 1000-1050.
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) 594-4613. 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 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.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
L. Matra
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications For Use Statement
510(k) Number (if known):
Elec-Mate E
Device Name:
Indications For Use:
The device is a control unit, which is connected to an ac power supply and a handpiece hose, that r rie do roo is a control and turns on or off or regulates the speed of the motor by the foot antrol of the dental unit. It has a provision for a low voltage dc power supply for the handpiece with light. It is intended as a control unit for the handpiece used in general dental applications for while it is to intended woth for crown preparation, cavity preparation, finishing the crown, inlay wothe filling, polishing, prophylaxis and endodontic treatment, with use of straight, right- and or the fining, ponsibiling, provithout internal coolant, of equal, step-up, or stepdown speed sheath. The maximum free speed of the electric micromotor is 40,000 rpm.
Special Note:
The electric micromotor and its cord are not autoclavable; therefore, an adequate covering by r he creeting as commonly used in dental for infection control method should be used during treatment.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | |
|---|---|
| OR | |
| Over-The-Counter Use | |
| (Division Sign-Off) | |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K041726 |
| (Optional Format 1-2-96) |