PROPHYFLEX 2, MODEL 2012

K973876 · Kavo America · EFB · Dec 19, 1997 · Dental

Device Facts

• Record ID: K973876
• Device Name: PROPHYFLEX 2, MODEL 2012
• Applicant: Kavo America
• Product Code: EFB · Dental
• Decision Date: Dec 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

The PROPHYflex 2 dental device is intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and sodium bicarbonate onto tooth surfaces. The product should not be used on patients on a saltless diet, with a renal deficiency, with a chronic respiratory disease, or with chronic diarrhea.

Device Story

PROPHYflex 2 is a dental device used by clinicians to remove plaque and stains from tooth surfaces. It operates by projecting a mixture of water, air, and sodium bicarbonate powder onto the teeth. The device is used in a clinical setting by dental professionals. It functions as a mechanical cleaning tool to improve oral hygiene and aesthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Air-water-sodium bicarbonate powder projection system. Handheld dental instrument. No software or electronic components.

Indications for Use

Indicated for removal of plaque and stains from teeth. Contraindicated for patients on saltless diets, or those with renal deficiency, chronic respiratory disease, or chronic diarrhea.

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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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and three human profiles are visible within the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Mr. Gregory W. Bowman Kavo America C/O Baker & McKenzie One Prudential Plaza 130 East Randolph Chicago, Illinois 60601

DEC 19 1997

K973876 Re : Trade Name: Prophyflex 2, Model 2012 Requlatory Class: I Product Code: EFB Dated: October 9, 1997 Received: October 10, 1997

Dear Mr. Bowman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Bowman

not affect any obligation you might have under sections 531 noc arress any obligation devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.pda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

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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## STATEMENT OF INDICATIONS FOR USE

510(k) Number:

Device Name: KaVo America PROPHYflex 2

Indications for Use:

The PROPHYflex 2 dental device is intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and sodium bicarbonate onto tooth surfaces. The product should not be used on patients on a saltless diet, with a renal deficiency, with a chronic respiratory disease, or with chronic diarrhea.

Concurrence of CDRH, Office of Device Evaluation ("ODE")

Savad Ruan

(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control, Division of B Hospital Devices KA 72 STU 510(k) Number --

Prescription Usel (Per 21 C.F.R. § 801.109)

OR

Over-the-Counter Use