CYBERSONIC

K980075 · American Dentronics, Inc. · LCN · Mar 4, 1998 · Dental

Device Facts

• Record ID: K980075
• Device Name: CYBERSONIC
• Applicant: American Dentronics, Inc.
• Product Code: LCN · Dental
• Decision Date: Mar 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6855
• Device Class: Class 1

Intended Use

Use to remove surface tongue debris, residue, plaque or filmy build-up that result from eating, drinking, smoking or other types of consumption which can lead to bad breath. Also may be used to remove salivary tongue plaques and residue that naturally accumulate during sleep or between cleanings.

Device Story

Cybersonic is a tongue cleaning device; removes surface debris, plaque, and filmy build-up from the tongue. Used by individuals to mitigate bad breath caused by consumption or natural accumulation during sleep. Operates as a manual or mechanical aid for oral hygiene. No complex electronics, software, or AI components described.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical tongue cleaning device. No energy source, software, or specific materials described in the provided documentation.

Indications for Use

Indicated for individuals seeking to remove tongue debris, plaque, or residue resulting from consumption (eating, drinking, smoking) or natural accumulation during sleep to reduce bad 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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

MAR - 4 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ronald K. Murayama, DDS American Dentronics, Incorporated 1350 East Flamingo Road, #573 Las Vegas, Nevada 89119

Re : K980075 Trade Name: Cybersonic Regulatory Class: Unclassified Product Code: LCN December 16, 1997 Dated: Received: January 8, 1998

## Dear Dr. Murayama:

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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ದಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as setforth 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 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 - Dr. Murayama

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 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 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,

Patricii Cucenide ffoe

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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510(k) Number (if known): klis0025

Device Name:

Indications For Use:

Use to remove surface tongue debris, residue, plaque or filmy build-up that result from eating, drinking, smoking or other types of consumption which can lead to bad breath. Also may be used to remove salivary tongue plaques and residue that naturally accumulate during sleep or between cleanings.

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Conc urrence of CDRH, Office of Device Evaluation (ODE) inner SUBOV

(Division Sign-Off) Division of Dental, Infection Control, and General Hospit 510(k) Number

Prescription Use | (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)