TOOTHBRUSH WASH

K994144 · Cal Huech, Inc. · EFW · Mar 2, 2000 · Dental

Device Facts

• Record ID: K994144
• Device Name: TOOTHBRUSH WASH
• Applicant: Cal Huech, Inc.
• Product Code: EFW · Dental
• Decision Date: Mar 2, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6855
• Device Class: Class 1

Intended Use

This product is intended to be used as an accessory to cleaning a toothbrush.

Device Story

The Toothbrush Wash is a manual accessory designed to assist in the cleaning of a toothbrush. It functions as a mechanical aid for hygiene maintenance. The device is intended for use by individuals to clean their toothbrushes. It does not involve electronic components, software, or automated processing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual accessory for toothbrush cleaning. No electronic, software, or complex material specifications provided.

Indications for Use

Indicated for use as an accessory for cleaning a toothbrush.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 2000 MAR

Ms. Cheryl A. Little President Cal Huech, Inc. 105 Settler's Trail 31088 Warner Robins, Georgia

K994144 Re : Toothbrush Wash Trade Name: Requlatory Class: I Product Code: EFW December 6, 1999 Dated: December 7, 1999 Received:

Dear Ms. Little:

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 general 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 aqainst 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. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of

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Page 2 -Ms. Little

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 regulation (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" (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,

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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This product is intended to be used as an accessory to cleaning a toothbrush.

Cheryl O. Little
Cheryl A. Little

12/06/1999
Date

K994144
*Premarket Notification 510(k) Number

Premarket Notification 510(k) Number

Susan Rurrer

(Division Sign-Off) (Division Sign-Off)
Division of Dental, Infection Control,
Division of Dental, Infection Devices , , , / / J Division of Dential The Boy
and General Hospital Day
510(k) Number ---------------------------------------------------------------------------------------------------------ાપા