MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS

K020776 · Coronet Group North America, LLC · EFW · Jun 3, 2002 · Dental

Device Facts

• Record ID: K020776
• Device Name: MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS
• Applicant: Coronet Group North America, LLC
• Product Code: EFW · Dental
• Decision Date: Jun 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6855
• Device Class: Class 1

Intended Use

The Medoral Hygienic Toothbrush with DENTOSAN® Filaments is a toothbrush to remove plaque and debris from the teeth and prevent tooth decay. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on and between the bristles after and between uses.

Device Story

Manual toothbrush featuring DENTOSAN® nylon filaments impregnated with silver antimicrobial agent; intended for over-the-counter use. Silver agent distributed throughout filament matrix provides long-lasting antimicrobial action to inhibit bacterial growth on and between bristles post-use. Device functions as standard manual toothbrush for plaque and debris removal; antimicrobial feature maintains brush cleanliness. No electronic components or software.

Clinical Evidence

Bench testing only. Testing included worst-case useful life, simulated use extraction, and antimicrobial efficacy. Biocompatibility testing performed according to ISO 10993 standards.

Technological Characteristics

Manual toothbrush. Nylon filaments impregnated with silver antimicrobial agent. Antimicrobial agent distributed throughout filament. Biocompatibility per ISO 10993.

Indications for Use

Indicated for general population use for removal of plaque and debris from teeth and prevention of tooth decay.

Regulatory Classification

Identification

A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.

Predicate Devices

• Reach Antibacterial Toothbrush (K971589)
• Crest Toothbrush with Microshield (K973236)
• Butler Antibacterial Interdental Toothbrush (K974761)

Submission Summary (Full Text)

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## Section E - 510(k) Summary

1020776

March 5, 2000

| Applicant: | CORONET GROUP North America, LLC<br>175 Dwight Road, Suite 200<br>Longmeadow, MA 01106<br>Phone: [phone] Fax: [phone] |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Application Preparer &<br>Correspondent | Thomas E. Ferari<br>Medical Device Consultant<br>181 Dixon Road<br>Queensbury, NY 12804<br>Phone - 518-792-2258 Fax: [phone]<br>email - [e-mail] |
| Proprietary Device Name:<br>Common Device Name:<br>Classification Name: | Medoral Hygienic Toothbrush with DENTOSAN® Filaments<br>Antibacterial Toothbrush Filament<br>Manual Toothbrush (Class I Device Ref 21CFR 872.6855) |
| Predicate Devices: | Reach Antibacterial Toothbrush K971589<br>Crest Toothbrush with Microshield K973236<br>Butler Antibacterial Interdental Toothbrush K974761 |

Device Description: The Medoral Hygienic Toothbrush is a toothbrush with DENTOSAN® filaments. The DENTOSAN® filament is a nylon filament impregnated with an anti bacterial agent to prevent the growth of bacteria on and between the filaments after use of the toothbrush.

Intended Use: The Medoral Hygienic Toothbrush is intended for over-the-counter use as a toothbrush. The antibacterial agent maintains the cleanliness of the brush by preventing the growth of bacteria on and between the filaments after use.

Technological Characteristics: The DENTOSAN® filament is impregnated with a high level of silver to prevent the growth of bacteria on or between the toothbrush bristles. The active ingredient is distributed throughout the nylon filament and provides long lasting antimicrobial action.

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Substantial Equivalence Assessment: All of the predicate devices are toothbrushes with antibacterial ingredients incorporated into them. Although the antibacterial agents (triclosan and chlorhexidine/zinc oxide) are different, in the predicate devices, their effect is comparable to the silver used in the DENTOSAN® filament. The effect of the antimicrobial agent was tested and found to be effective using worst case testing for useful life, simulated use extraction testing and antimicrobial effectivity. Additionally, the filament was determined to be biocompatible using the methods recommended in ISO 10993 Biological Testing of Medical and Dental Materials and Devices.

## Summary:

The antimicrobial agent used is the DENTOSAN® filament does not raise any new safety or effectiveness concerns. The biocompatibility and effectiveness of the antibacterial agent was tested using established scientific methods and test protocols. Therefore, the Medoral Hygienic Toothbrush with DENTOSAN® filaments is believed to be substantially equivalent to the predicate devices.

Image /page/1/Picture/3 description: The image shows the date 3/5/02. The date is written in a simple, sans-serif font. The numbers are clearly legible.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular 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 right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 0 3 2002

C/O Mr. Thomas E. Ferari Medical Device Consultant Coronet Group North America, LLC 181 Dixion Road Queensbury, New York 12804

Re: K020776

Trade/Device Name: Medoral Hygienic Toothbrush with DENTOSAN® Filaments Regulation Number: 872.6855 Regulation Name: Toothbrush with Antibacterial Filament Regulatory Class: I Product Code: EFW Dated: March 5, 2002 Received: March 11, 2002

Dear Mr. Ferari

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.

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

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Page 2 - Mr. Ferari

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]dditionally, 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). 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,

Patricio Cusenite ffor

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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K02076

## Section D - Statement of Indications for Use

| 510(k) Number: | TBD |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | CORONET GROUP North America, LLC<br>175 Dwight Road, Suite 200<br>Longmeadow, MA 01106<br>Phone: [phone] Fax: [phone] |
| Proprietary Device Name: | Medoral Hygienic Toothbrush with DENTOSAN® Filament |

Intended Use: The Medoral Hygienic Toothbrush with DENTOSAN® Filaments is a toothbrush to remove plaque and debris from the teeth and prevent tooth decay. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on and between the bristles after and between uses.

ABgotz for Dr Ruener

(Division Sign Division of Dental, Infection Control, and General Hospital 5 10(k) Number _