BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH

K974761 · John O. Butler Co. · EFW · Jun 16, 1998 · Dental

Device Facts

• Record ID: K974761
• Device Name: BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH
• Applicant: John O. Butler Co.
• Product Code: EFW · Dental
• Decision Date: Jun 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6855
• Device Class: Class 1

Intended Use

The Butler Antibacterial Interdental Toothbrush is intended to remove adherent plaque and food debris from between the teeth to reduce tooth decay. The addition of the antibacterial agent is intended to maintain the cleanliness of the interdental brush between uses and to have no effect on the user of the device.

Device Story

Manual interdental toothbrush; incorporates antibacterial agent to maintain brush cleanliness between uses; agent has no therapeutic effect on user. Used by patients for oral hygiene; removes plaque and food debris from interdental spaces to reduce tooth decay.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual interdental toothbrush; incorporates antibacterial agent for brush hygiene; Class I device; Product Code EFW.

Indications for Use

Indicated for the removal of adherent plaque and food debris from between the teeth to reduce tooth decay in the general population.

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.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 6 1998

John O. Butler Company C/O Mr. Thomas J. Muldoon Burditt & Radzius, Chartered 333 West Wacker Drive, Suite 2600 Chicago, Illinois 60606-1218

Re : K974761 Butler Antibacterial Interdental Toothbrush Trade Name: Regulatory Class: I Product Code: EFW Dated: March 19, 1998 Received: March 20, 1998

## Dear Mr. Muldoon:

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 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). 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 (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. ਸਿ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that,
through periodic QS inspections, the Food and Drug Administration (FD/) 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 Reqister. 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. Muldoon

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 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 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/dsma/dsmamain.html".

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Sincerely yours,

Timothy A. Ulatowski

Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure -------

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510(k) Number (if known):

Device Name: Butler Antibacterial Interdental Toothbrush

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Indications For Use:

Interdental Toothbrush । Antibacterial The Butler intended to remove adherent plaque and food debris from between the teeth to reduce tooth decay. The addition of the antibacterial agent is intended to maintain the cleanliness of the interdental brush between uses and to have no effect on the user of the device.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Super Risser
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(Div:
D
fection Control,
and Conspital Devices
510(k) Number K97474)

Prescription Use
(21 CFR 801.109) OR Over-the-counter Use

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