The Elite low speed air motor with Elite "E" contra-angle is to power various attachments which helps the dental clinician perform various dental procedures, removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth.

The Medidental high speed handpiece is an air-powered dental handpiece which helps the dental clinician perform various dental procedures such as removing carious material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth.

Device Description

AI/ML Overview

This is a 510(k) premarket notification for a dental handpiece, not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, expert involvement, MRMC study, standalone performance, ground truth, and training set is not applicable.

The provided document describes the substantial equivalence determination for:

Trade Name: Elite Low Speed Air Motor with Elite "E" Contra-angle, Medidental High Speed Handpiece
Common Name: Air-powered Low Speed Handpiece, E Type contra-angle, Air-powered High Speed Handpiece
Classification Name: Handpiece, Air-Powered Dental
Product Code: EFB (later listed as EFA in the FDA letter, which could be a typo or an update)

The device is intended to power various attachments for dental procedures such as removing carious material, excess filling material, cavity and crown preparation, root canal preparations, restoration, and polishing teeth.

The device was found substantially equivalent to the predicate device:

Predicate Device: High & Low Speed Handpiece, with E-Type contra-angle (K073652) manufactured by NAKAMURA MAGNIFIER CO., LTD.

The FDA's review for such devices typically focuses on comparing the new device's technological characteristics and performance to a legally marketed predicate device to ensure it is as safe and effective. This generally involves mechanical and performance testing relevant to its function as a dental handpiece, such as speed, torque, vibration, noise, and compatibility with attachments, but not AI/ML-specific metrics.

Summary

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K090055

Image /page/0/Picture/1 description: The image shows a logo for DPM CORP. USA General Products Manufacture. The logo is in black and white and features the letters DPM in large, bold font. The word CORP. is written in smaller font below the letters DPM. The word USA is written in smaller font to the right of the letters DPM. The words General Products Manufacture are written in smaller font below the word USA.

OCT 2 7 2009

October 9, 2009

Section III - 510(k) 090055

Summary of Safety and Effectiveness

Submitter:

DPM USA Corp. 1460 NW 107 Ave Suite G Miami. Florida 33172 Phone: 305-640-9894 Fax: 305-477-3206 Contact Person: George Echeverri

Summary Prepared Date: October 9, 2009

Device Name:

Trade Name- Elite Low Speed Air Motor with Elite "E" contra-angle, Medidental 1. high speed handpiece
II. Common Name- Air-powered Low Speed Handpiece, E Type contra-angle, Airpowered High Speed Hanpiece
III. Classification Name- Handpiece, Air-Powered Dental
IV. Classification Number:21 CFR 872.4200
V. Product Code: EFB

Device for Which Substantial Equivalence is Claims:

1. High & Low Speed Handpiece, with E-Type contra-angle
1. 510 (k) 073652
1. Manufacture: NAKAMURA MAGNIFIER CO., LTD.

Device Description / Intended Use:

The Medidental high speed handpiece is an air-powered dental handpiece which helps the dental clinician perform various dental procedures such as removing canous material and excess filling material, cavity and crown preparation, root canal preparations, restoration and polishing teeth.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Mr. George Echeverri DPM USA Corporation 1460 NW 107 Avenue, Suite G Miami, Florida 33172

OCT 2 7 2009

Re: K090055

Trade/Device Name: Elite Low Speed Air Motor with Elite "E" Contra-angle, Medidental High Speed Handpiece Regulation Number: 21CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFA Dated: October 9, 2009 Received: October 13, 2009

Dear Mr. Echeverri:

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 additional controls. Existing major regulations affecting your 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.

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Page 2- Mr. Echeverri

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm,

Sincerely yours,

foc

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if know): 090055

Device Name: Elite Low Speed Air Motor with Elite "E" contra-angle, Medidental high speed handpiece

Indications for Use:

Prescription Use X Use

AND/OR

Over-The-Counter

(21 CFR Part 801 Subpart D)

(21 CFR Part 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein. Hulsey for MSR
Division Sign-Off)

vision of Anesthesiology, General Hospital · rection Control, Dental Devices

K090055 10(k) Number:

Regulation Number and Section

§ 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.