PROPHY-MATE

K032395 · Nakanishi, Inc. · EFB · Oct 17, 2003 · Dental

Device Facts

• Record ID: K032395
• Device Name: PROPHY-MATE
• Applicant: Nakanishi, Inc.
• Product Code: EFB · Dental
• Decision Date: Oct 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Prophy-Mate device is intended for use in dental applications to remove stains and plaque deposits from the teeth by shooting a mixture of sodium bicarbonate powers, air, and water onto tooth surfaces.

Device Story

Prophy-Mate is a dental handpiece used by dental professionals to remove stains and plaque. Device operates by pneumatically delivering a mixture of sodium bicarbonate powder, air, and water onto tooth surfaces. Used in clinical dental settings. Output is a pressurized spray that mechanically abrades and cleans tooth enamel. Benefits include efficient removal of dental deposits.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental handpiece for air-polishing. Operates via compressed air and water supply mixed with sodium bicarbonate powder. Mechanical cleaning principle. Class I device.

Indications for Use

Indicated for removal of dental stains and plaque. Contraindicated for patients with salt intake restrictions (hypernatremia, toxemia of pregnancy), digestive organ ulcers, dyshepatia, cardiac or lung dysfunction, oral damage/abnormality, oral congestion/bleeding/inflammation, contact lens wearers, allergies, or tendency for oral mucous membrane inflammation/soreness.

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol is a representation of a human figure embracing a bird, which is meant to symbolize the department's mission of protecting the health of all Americans and providing essential human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 7 2003

Mr. Hiroji Sekiguchi International Division II Manager Nakanishi, Incorporated 700 Shimohinata Kanuma-Shi. Tochigi-Ken 322-8666 JAPAN

Re: K032395

Trade/Device Name: Prophy-Mate Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: July 31, 2003 Received: August 08, 2003

Dear Mr. Sekiguchi:

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 - Mr. Hiroji Sekiguchi

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 vour 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.

Patricia Cuanto/for

Chiu S. Lin, PhD 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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Indications For Use Statement

| 510(k) Number (if known): | 2032395 |
|---------------------------|-------------|
| Device Name: | Prophy-Mate |

Indications For Use:

The Prophy-Mate device is intended for use in dental applications to remove stains and plaque deposits from the teeth by shooting a mixture of sodium bicarbonate powers, air, and water onto tooth surfaces.

This product should not be used on patients who are restricted of salt intake (hypernatremia, toxemia of pregnancy); or with critical ulcers in digestive organs, dyshepatia, cardial or lung dysfunction, damage or abnormality in a mouth, congestion, bleeding or inflammation in a mouth, contact lenses, or allergies; or who tend to have inflammation or soreness in the in the oral mucous membrane.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rmor

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

K032-393

Prescription Use (Per 21 CFR 801.109)

OR

510(k) Number:

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)