(58 days)
Not Found
No
The device description details a simple, non-electronic, plastic tongue cleaner with no mention of any computational or data-driven features.
No
The device is described as a tongue cleaner for removing plaque and food debris, which is for hygiene and cosmetic purposes (fresher breath), not for treating or preventing disease.
No
The device is described as a tongue cleaner used for removing plaque and food debris, which is a therapeutic rather than a diagnostic function. There is no mention of it being used to detect or assess a medical condition.
No
The device description clearly states it is a physical object made of plastic, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Breath-So-Fresh tongue cleaner is a physical tool used to mechanically remove debris from the surface of the tongue. It does not analyze any biological specimens.
- Intended Use: The intended use is to remove plaque and food debris for oral hygiene and fresher breath, not for diagnosing any medical condition based on analysis of a specimen.
The device description and intended use clearly indicate a physical cleaning tool, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
To remove bacterial plaque and food debris from the surface of the tongue, promoting clean mouth and fresher breath.
Product codes
ICN
Device Description
The Breath-So-Fresh tongue cleaner is molded to a modified "spoon-shape". One end of the tongue cleaner is a handle. The other end is shaped as the bowl of the spoon. The tongue cleaner is held as a spoon, except upside down. The end tip of the spoon end is mildly rippled but has no sharp edges. The total length of the Breath-So-Fresh tongue cleaner is seven inches long and the cleaner is one and one-fourth inches wide at the widest portion.
The Breath-So-Fresh tongue cleaner is composed of a hard white plastic, either a polycarbonate plastic or a plastic similar to polycarbonate. This plastic is flexible as well as durable and is well suited to dental applications. The tongue cleaner is designed so that there are no sharp edges to the plastic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tongue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6855 Manual toothbrush.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
0
SEP 1 1997
510 (K) Summary of Safety and Effectiveness for Breath-So-Fresh Tongue Cleaner
International Dental Design Specialists, Inc. 829 Ninth Street, Imperial Beach, California 91932 Telephone: (619) 424-5115 Fax: (619) 424-5128
1) SUBMITTER:
| Name: | International Dental Design Specialists, Inc. |
|---|---|
| Address: | 629 Ninth Street, Imperial Beach, CA 91932 |
| Telephone: | (619) 424-5115 |
| Fax: | (619) 424-5128 |
| Contact Person: | Clifford Yudelman |
| Date: | July 11, 1997 |
2) NAME OF DEVICE:
| Proprietary Name: | Breath-So-Fresh Tongue Cleaner |
|---|---|
| Common/Usual Name: | Tongue Scraper/Tongue Cleaner |
| Classification Name: | Tongue Scraper |
3) PREDICATE DEVICES:
"The Professional Tongue Cleaner" (K961660)
"Oolitt Tongue Cleaner" (K962941)
4) DESCRIPTION OF DEVICE
The Breath-So-Fresh tongue cleaner is molded to a modified "spoon-shape". One end of the tongue cleaner is a handle. The other end is shaped as the bowl of the spoon. The tongue cleaner is held as a spoon, except upside down. The end tip of the spoon end is mildly rippled but has no sharp edges. The total length of the Breath-So-Fresh tongue cleaner is seven inches long and the cleaner is one and one-fourth inches wide at the widest portion.
The Breath-So-Fresh tongue cleaner is composed of a hard white plastic, either a polycarbonate plastic or a plastic similar to polycarbonate. This plastic is flexible as well as durable and is well suited to dental applications. The tongue cleaner is designed so that there are no sharp edges to the plastic.
5) INTENDED USE
To remove bacterial plaque and food debris from the surface of the tongue, promoting clean mouth and fresher breath.
6) TECHNOLOGICAL CHARACTERISTICS
The shape of the Breath-So-Fresh Tongue Cleaner is similar to the predicate device, the Professional Tongue Cleaner (K961660) in that both have a sturdy handle at one end and a rounded portion for placement on the tongue on the other end. The Breath-So-Fresh Tongue Cleaner combines this design with another feature: a rippled cleaning edge. Both the Breath-So-Fresh and the Oolitt (K962941) tongue cleaners have a rippled edge to enhance tongue scraping.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that suggest movement and flight. The overall design is simple and clean, with a focus on the eagle as a symbol of the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Clifford Yudelman International Dental Design Specialists, Incorporated 629 Ninth Street
SEP 1 1 1997
91932 Imperial Beach, California
K972644 Re : Breath-So-Fresh Tongue Cleaner Trade Name: Regulatory Class: Unclassified Product Code: ICN Dated: July 11, 1997 Received: July 15, 1997
Dear Mr. Yudelman:
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 reguirements 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. ਸੈ 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 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
2
Page 2 - Mr. Yudelman
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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 Radioloqical Health
Enclosure
3
510(k) Number (if known):
Device Name:_Tongue_Cleaner
Indications For Use:
To remove bacterial plaque and food debris from the surface of the tongue, promoting clean mouth and fresher breath.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ringer
(Division Sign-Off) Division of Dental, Inf and General Hospital De 510/k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)