PROPHYPEARLS

K031868 · Kavo America · EFB · Jul 9, 2003 · Dental

Device Facts

• Record ID: K031868
• Device Name: PROPHYPEARLS
• Applicant: Kavo America
• Product Code: EFB · Dental
• Decision Date: Jul 9, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

PROPHYpearls is a powder intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and calcium carbonate onto tooth surfaces.

Device Story

PROPHYpearls is a dental cleaning powder used with an air-powered dental handpiece. The device functions by projecting a mixture of water, air, and calcium carbonate onto tooth surfaces to remove plaque and stains. It is intended for use by dental professionals in a clinical setting. The device is a modification of the previously cleared PROPHYflex 2 system, replacing the original sodium bicarbonate powder with calcium carbonate, which is biocompatible and recognized as a safe food substance. The output is the physical removal of dental deposits, aiding in oral hygiene maintenance.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by the biocompatibility and safety profile of the calcium carbonate material and comparative performance studies.

Technological Characteristics

Cleaning powder consisting of calcium carbonate. Used with air-powered dental handpieces (Product Code EFB). The device is a consumable powder modification for an existing handpiece system.

Indications for Use

Indicated for the removal of plaque deposits and stains from tooth surfaces in dental patients.

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.

Predicate Devices

• PROPHYflex 2 (K973876)

Submission Summary (Full Text)

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EXHIBIT 2 KaVo America Corporation 340 East Main Street Lake Zurich, Illinois 60047 Toll Free: 800 323 8029 Tel: 847 / 550 - 6800 Fax: 847 / 550 - 6825 e-mail: [e-mail] Contact: John Franz, President June 12, 2003 510(k) Summary of Safety and Effectiveness

- Identification of the Device: 1. Proprietary-Trade Name: KaVo PROPHYpearls Classification Name: HANDPIECE, AIR-POWERED, DENTAL, Product Code EFB Common/Usual Name: Cleaning powder for use with dental handpiece
- 2. Equivalent legally marketed device: This product is similar in design and identical in function to PROPHYflex 2 (K973876) (powder).
- 3. Indications for Use (intended use): PROPHYpearls is a powder intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and calcium carbonate onto tooth surfaces.
- 4. Description of the Device: This submission is for a modification of a device system cleared under K973876, the PROPHYflex 2 Dental Device. The predicate system consists of a handpiece and powder combination which 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 modification involves changing the powder from sodium bicarbonate to calcium carbonate. Calcium carbonate is a substance which is inherently biocompatible, and studies have shown that the calcium carbonate powder does an equal or better job of removing plaque. Calcium carbonate is recognized in the Code of Federal Regulations as a food substance generally recognized as safe.

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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 symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

9 2003 JUL

KaVo America Corporation C/O Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K031868

Trade/Device Name: PROPHYpearls Regulation Number: 21 CFR 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: I Product Codes: EJR, EFB Dated: June 16, 2003 Received: June 26, 2003

Dear Mr. Kamm:

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 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 - Daniel Kamm, P.E.

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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), 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" (21CFR Part 807.97) you may obtain. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Susan Runner

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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j) Indications for Use

510(k) Number

Device Name: .

Indications for Use: PROPHYpearls is a powder intended for use in removing plaque deposits and stains from teeth by projecting a mixture of water, air, and calcium carbonate onto tooth surfaces.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over the Counter Use_ Prescription Use OR (Per 21 CFR 801.109)

Ken Ruby for MSR

hesiology. General Hospital.

510(k) Number: K 031868