(83 days)
The device is a control unit, which is connected to an ac power supply and a handpiece hose, that is a control and turns on or off or regulates the speed of the motor by the foot control 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 crown preparation, cavity preparation, finishing the crown, inlay 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.
The device is a control unit, which is connected to an ac power supply and a handpiece hose, that is a control and turns on or off or regulates the speed of the motor by the foot control of the dental unit. It has a provision for a low voltage dc power supply for the handpiece with light.
The provided text is a 510(k) clearance letter from the FDA for the "Elect-Mate E" device, an Electric Control Unit with Micromotor. It primarily addresses the device's substantial equivalence to a predicate device and its intended uses.
However, the document does NOT contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot provide the requested table or answer the specific questions related to the study design and results based on the given text.
The document only states that:
- The device is an "Electric Control Unit with Micromotor."
- Its regulation number is "872.4200" and regulatory class is "I."
- It is intended for general dental applications, including crown preparation, cavity preparation, finishing the crown, inlay/filling, polishing, prophylaxis, and endodontic treatment.
- It has a maximum free speed of the electric micromotor of 40,000 rpm.
- The electric micromotor and its cord are not autoclavable, requiring adequate covering for infection control.
To answer your questions, I would need a document detailing the actual performance studies conducted for the Elect-Mate E device.
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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
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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
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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) |
§ 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.