BREATH ACE BREATHFRESHENER

K972131 · Beyond 21st Century, Inc. · LCN · Jul 18, 1997 · Dental

Device Facts

• Record ID: K972131
• Device Name: BREATH ACE BREATHFRESHENER
• Applicant: Beyond 21st Century, Inc.
• Product Code: LCN · Dental
• Decision Date: Jul 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6855
• Device Class: Class 1

Intended Use

To remove food and debri from the mouth resulting in fresher breath.

Device Story

Breath Ace Breathfreshener is a device designed for oral hygiene. It functions by removing food particles and debris from the mouth to improve breath freshness. It is intended for over-the-counter use by consumers. The device provides a mechanical means of oral cleaning to assist in maintaining breath hygiene.

Clinical Evidence

No clinical data provided; bench testing only.

Indications for Use

Indicated for individuals seeking to remove food and debris from the mouth to achieve fresher breath.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hemant K. Thakur, M.D. President & C.E.O Beyond 21ST Century, Incorporated >> 13706 West 75th Place Lenexa, Kansas 66216-4229

JUL 18 1997

K972131 Re : Breath Ace Breathfreshener Trade Name: Requlatory Class: Unclassified Product Code: LCN Dated: June 4, 1997 Received: June 6, 1997

Dear Dr. Thakur:

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, qood 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 (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 - Dr. Thakur

through 542 of the Act for devices under the Electronic chrough 312 or enc 110 rovisions, 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 ... ... ating of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markets produce, 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" (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

Timo 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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510(K) Number: K972131 Device Name: Breath Ace Breathfeshener

Indications For Use:

To remove food and debri from the mouth resulting in fresher breath.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dentat, Infection Control,
and General Hospital Devices
510(k) Number 972131

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use_

(optional Format 1-2-96)