MIRACLEBREATH TONGUE CLEANER

K992270 · Stellar Labs, Inc. · LCN · Sep 23, 1999 · Dental

Device Facts

• Record ID: K992270
• Device Name: MIRACLEBREATH TONGUE CLEANER
• Applicant: Stellar Labs, Inc.
• Product Code: LCN · Dental
• Decision Date: Sep 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6855
• Device Class: Class 1

Intended Use

To remove plaque and food debris from the surface of the tongue and to help fight bad breath and promote oral hygiene.

Device Story

MiracleBreath Tongue Cleaner is a manual oral hygiene device. Constructed from a natural polypropylene band formed into a U-shape. Operated by the user by holding each end with fingertips, placing the device on the back of the tongue, and pulling forward with either the flat or rippled edge. No sharp edges. Used for removal of plaque and food debris from the tongue surface to promote oral hygiene and mitigate bad breath.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Natural polypropylene. Form factor: U-shaped band. Operation: Manual, non-powered. No electronic components or software.

Indications for Use

Indicated for individuals seeking to remove plaque and food debris from the tongue surface to improve oral hygiene and 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.

Predicate Devices

• Oolitt Tongue Cleaner (K962941)
• Unik Tongue Cleaner (K983683)

Submission Summary (Full Text)

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K992270

# 510(K) Summary [As required by 21 CFR Section 807.92 (c)]

#### 1. Contact Information

| Submitter: | Stellar Labs, Inc. |
|-----------------|-----------------------------------------------|
| Address: | 5604 Marengo Road<br>Bethesda, Maryland 20816 |
| Telephone: | 301.320.1217 |
| Facsimile: | 301.320.1217 |
| Contact Person: | Harlan Pomeroy III |
| Telephone: | 941.926.7745 |
| Facsimile: | 941.926.2512 |
| Date Prepared: | Wednesday, June 30, 1999 |

# 2. Name of Device

| Proprietary Name: | MiracleBreath Tongue Cleaner |
|----------------------|-------------------------------|
| Common Name: | Tongue Scraper/Tongue Cleaner |
| Classification Name: | Tongue Scraper |

## 3. Predicate Devices

"Oolitt Tongue Cleaner" (K962941)

"Unik Tongue Cleaner" (K983683)

## 4. Description of Device

The device is a natural polypropylene band. It is formed into a u-shape by holding each end with the finger tips. The device is then placed on the back of the tongue and pulled forward gently with either the flat or rippled edge down. There are no sharp edges on the device.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 1999

Mr. Harlan Pomeroy III Senior Vice President Stellar Labs, Incorporated 6637 Superior Avenue, Suite D Sarasota, Florida 34231

Re: K992270 Miraclebreath Tonque Cleaner Trade Name: Regulatory Class: Unclassified Product Code: LCN Dated: June 30, 1999 Received: July 6, 1999

Dear Mr. Pomeroy:

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 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 requlatory 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 -Mr. Pomeroy

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 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,

Patricia Cusanti //for

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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Figure 1

510(k) Number (if known):_

MiracleBreath Tongue Cleaner Device Name:

Indications For Use:

To remove plaque and food debris from the surface of the tongue and to help fight bad breath and promote oral hygiene.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumpe/

(Division Sign-Off) (Division Bigh Olyn Control, and General Hospital Devices
EACVIA Number 510(k) Number -

Prescription Use (Pcr 21 CFR 801.109)

OR

**Over-The-Counter Use**

(Optional Format 1-2-96)