← Product Code [MMD](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/MMD) · K971639 # PLUSTRON ION TOOTHBRUSH SYSTEM (K971639) _Sas Group, Inc. · MMD · Jun 24, 1997 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/MMD/K971639 ## Device Facts - **Applicant:** Sas Group, Inc. - **Product Code:** [MMD](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/MMD.md) - **Decision Date:** Jun 24, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.6865 - **Device Class:** Class 1 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines that suggest movement or progress. 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 {1}------------------------------------------------ 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 (301) 594-4618. Additionally, for questions on eem reason and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 {2}------------------------------------------------ ## REVISED 6/11/97 I । of Pagc 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 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | 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
(Per 21 CFR 801.109) | OR | Over-The-Counter Use | (Optional Format 1-2-96) TT AIR HHHHN THEFTS & MICHHMMHK : பர --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/MMD/K971639](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/MMD/K971639) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com