PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399

K100854 · Premium Plus International Limited · EGS · Dec 9, 2010 · Dental

Device Facts

• Record ID: K100854
• Device Name: PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399
• Applicant: Premium Plus International Limited
• Product Code: EGS · Dental
• Decision Date: Dec 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

The Premium Plus Disposable Prophy Angle Model 3399 is intended to be attached to a low speed dental handpiece and used by professional dentists and dental hygienists for polishing and cleaning the surface of teeth. The Premium Plus Disposable Prophy Angle is intended for single use, thus eliminating the possibility of cross contamination. It is intended to be used for a single patient and should be discarded after each patient.

Device Story

Premium Plus Disposable Prophy Angle (Model 3399) is a dental accessory designed for attachment to low-speed dental handpieces. Operated by dentists or dental hygienists in clinical settings, the device facilitates the polishing and cleaning of tooth surfaces. The device is intended for single-patient use to eliminate cross-contamination risks and is discarded after each procedure.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Disposable dental prophy angle; mechanical attachment to low-speed dental handpiece; single-use design.

Indications for Use

Indicated for use by dentists and dental hygienists for polishing and cleaning tooth surfaces. Single-patient use only.

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

Mr. Dennis NG Premium Plus International Limited Flat 1601 Yuen Long Trading Centre No. 33 Wang Yip Street West, Yuen Long Nt Hong Kong, China

DEC - 9 2010

Re: K100854

Trade/Device Name: Premium Plus Disposable Prophy Angle Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: November 8, 2010 Received: November 8, 2010

Dear Mr. Ng:

We have reviewed your Section 510(k) premarket notification of intent to market the device we mave to rowed your 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 Interstate conmisered pror to ria, 20, ceen reclassified in accordance with the provisions of Amendinents, or to devroes that have of Act (Act) that do not require approval of a premarket the rederal I ood, Drug, und Commons , therefore, market the device, subject to the general approval application (11.11). I The general controls provisions of the Act include controls provisions of the Fiel. The ginting of devices, good manufacturing practice, requirences for annual registration, monding 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 If your device is classinod (000 as 10) controls. Existing major regulations affecting your (FMA), It may be subject to additions, Title 21, Parts 800 to 898. In the Fode device can be found in the Sous of Forcerning your device in the Federal Register.

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## Page 2- Mr. Ng

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 3 issualled on a bacements with other requirements mean that ITDA has made a deceminations administered by other Federal agencies. of the Act of ally I oderal blances and systements, including, but not limited to: registration Tourings comply with an the : 100 : 100 eing (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing of (reporting of medical device related as versions (QS) regulation (21 CFR Part 820);
practice requirements as set forth in the quality systems (QS) regulation (21 CFR Parts of practice requirements as section to use 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/ucml 15809.htm for mtp.//www.rad.gov/r.cour.gov/room/ Health's (CDRH's) Office of Compliance. Also, the Center 10. 150 more an 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

MDK regulation (21 CFR Purt 003); prease go v Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Tourner 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 vours,

Susan Riwer

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiolgy, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## PREMIUM PLUS INTERNATIONAL LIMITED

Flat 1601 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long KONG

Telephone : [phone], Facsimile : (852) 2761 3210, Email : [e-mail]

## Indications for Use

510(k) Number (if known): K 100584

DEC - 9 2010

Device Name: Premium Plus Disposable Prophy Angle

Indications For Use:

"The Premium Plus Disposable Prophy Angle Model 3399 is intended to be attached to a low speed dental handpiece and used by professional dentists and dental hygienists for polishing and cleaning the surface of teeth. The Premium Plus Disposable Prophy Angle is intended for single use, thus eliminating the possibility of cross contamination. It is intended to be used for a single patient and should be discarded after each patient."

YES Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

NO

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Susan |
|--|----------------------------------------------|
| | (Division Sign-Off) |
| | Division of Anesthesiology, General Hospital |
| | Infection Control, Dental Devices |

| 510(k) Number: | K100854 |
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| Page 1 of | 1 |