ZEN CORDLESS PROPHY SYSTEM

K101612 · Discus Dental, LLC · EKX · Jun 30, 2010 · Dental

Device Facts

• Record ID: K101612
• Device Name: ZEN CORDLESS PROPHY SYSTEM
• Applicant: Discus Dental, LLC
• Product Code: EKX · Dental
• Decision Date: Jun 30, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

The Zen Cordless Prophy System is a high-performance cordless prophylaxis handpiece with a wireless foot pedal for use with Zen's disposable prophylaxis angles to clean and polish teeth.

Device Story

Zen Cordless Prophy System is a cordless dental handpiece paired with a wireless foot pedal. Used by dental professionals in clinical settings to clean and polish teeth. Device accepts disposable prophylaxis angles as input. Operates via wireless control to rotate the prophy angle for mechanical cleaning/polishing of tooth surfaces. Benefits include improved ergonomics and mobility by eliminating cord tethering during dental procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Cordless handpiece; wireless foot pedal; mechanical rotation for prophylaxis angles. Class I device. No complex software or electronic sensing described.

Indications for Use

Indicated for use by dental professionals to clean and polish teeth using disposable prophylaxis angles.

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Discuss Dental, LLC C/O Mr. Jeff D. Rongero Responsible Third Party Official . Underwriters Laboratories, Incorporated 12 Laboratory Drive Research Triangle, North Carolina 27709

JUN 3 0 2010

Re: K101612

Trade/Device Name: Zen Cordless Prophy System Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: June 24, 2010 Received: June 25, 2010

Dear Mr. Rongero:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Rongero

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

hn for

Anthony D. Watson, B.S., M.S., M.B.A. 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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K101612

## E. Indications for Use Statement

510(k) Number: .

Device Name: Zen Cordless Prophy System

## Intended Use

.

The Zen Cordless Prophy System is a high-performance cordless prophylaxis handpiece with a wireless foot pedal for use with Zen's disposable prophylaxis angles to clean and polish teeth.

Prescription Use x (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Lei Muly for MSE
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K101612

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