PLUSTRON ION TOOTHBRUSH SYSTEM

K971639 · Sas Group, Inc. · MMD · Jun 24, 1997 · Dental

Device Facts

• Record ID: K971639
• Device Name: PLUSTRON ION TOOTHBRUSH SYSTEM
• Applicant: Sas Group, Inc.
• Product Code: MMD · Dental
• Decision Date: Jun 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6865
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

For the removal of plaque For cleaning teeth For healthier gums For fresh breath

Device Story

PlusTron Ion Toothbrush System is an oral hygiene device designed for plaque removal and gum health. Device utilizes ion technology to assist in cleaning teeth and freshening breath. Operated by the user at home as a manual or powered toothbrushing aid. Output is mechanical cleaning of tooth surfaces; clinical benefit includes improved oral hygiene and plaque reduction. Healthcare providers may recommend use as part of routine dental care.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ion-based toothbrush system; intended for oral hygiene. Specific materials, dimensions, and energy source details not provided in the document.

Indications for Use

Indicated for plaque removal, tooth cleaning, gum health improvement, and breath freshening for general population use.

Regulatory Classification

Identification

A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael D. Sobo ·President SAS Group, Incorporated 220 White Plains Road Tarrytown, New York 10591

JUN 24 1997

Re: K971639 Trade Name: Plustron Ion Toothbrush System Requlatory Class: Unclassified Product Code: MMD Dated: April 25, 1997 Received: May 2, 1997

Dear Mr. Sobo:

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 qeneral controls provisions The general controls provisions of the Act 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 (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 Cood Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Sobo

through 542 of the Act for 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 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 requlation (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 eem reason 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.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Patricea Cucenti / foc

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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## REVISED 6/11/97

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к97-1639 510(k) Number (if known): _

Device Name:_ PlusTron Ion Toothbrush System

Indications For Use:

For the removal of plaque For cleaning teeth For healthier gums For fresh breath

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|---------------------------------------------------------------------|---------|----------------------|
| (Division Sign-Off) | | |
| Division of Dental, Infection Control, and General Hospital Devices | | |
| 510(k) Number | K971639 | |
| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |

(Optional Format 1-2-96)

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