(50 days)
K/DEN numbers for Reference Device(s): Not Found
No
The device description and the lack of any mention of AI, ML, or related concepts indicate a simple mechanical device.
No
The device is described as a simple tool for oral hygiene to remove plaque from the tongue, without any indication of therapeutic treatment for a disease or condition. The indicated use is purely for hygiene.
No
Explanation: The device is described as a "simple device which is used to scrape build up of plaque from the surface of the tongue" for oral hygiene. It does not appear to identify, measure, or monitor a health condition, which are characteristics of a diagnostic device.
No
The device description explicitly states it is a "simple device which is used to scrape build up of plaque from the surface of the tongue," implying a physical scraping mechanism, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Tongue Klean's Function: The description clearly states that Tongue Klean is a device used to scrape build up of plaque from the surface of the tongue. This is a mechanical action performed on the body, not a test performed on a sample taken from the body.
- Lack of Diagnostic Information: The intended use is for oral hygiene and plaque removal, not for diagnosing any disease or condition.
Therefore, Tongue Klean falls under the category of a general medical device used for physical cleaning, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
TONGUE KILEAN ાં ટ INDICATED for ೧೭೯ નિર્ડ PART THE ORAL HYSIENE DALLY TO OF FROM THE SURFACE PLAQUE REMOVE TONGUE Of THE
Product codes
LCN
Device Description
Softek's Tongue Klean is a simple device which is used to scrape build up of plaque from the surface of the tongue. Tongue Klean is easy to use and does not present any undue risk to the user of Tongue Klean.
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)
K 962941
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
OCT 1 4 1997
SUMMARY OF 510(k)
TRADE NAME: Tongue Klean CLASSIFICATION NAME: Tongue Scraper COMMON NAME: Tongue Scraper
OOLITT, D.T. Corp., Premarket Notification K 962941 Predicate Device:
Device Description
Softek's Tongue Klean is a simple device which is used to scrape build up of plaque from the surface of the tongue. Tongue Klean is easy to use and does not present any undue risk to the user of Tongue Klean.
Substantial Equivalency:
Softek Tongue Klean is similar in design and has the same Technological characteristics as "OOLITT" and has same indications for use.
1
Image /page/1/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three overlapping shapes that resemble human figures or birds in flight, creating a sense of movement and unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Promila Gupta Softek Enterprises 5245 S. Hanover Way Englewood, Colorado 80111
OCT 1 4 1997
Re : K973175 Tongue Klean Trade Name: Regulatory Class: Unclassified Product Code: LCN Dated: August 18, 1997 Received: Auqust 25, 1997
Dear Mr. Gupta:
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 Requlation (QS) for Medical Devices: General requlation (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 requlatory 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
2
Page 2 - Mr. Gupta
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
Ulatowski Timot y A. 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 KLEAN |
| Indications For Use: |
TONGUE KILEAN ાં ટ INDICATED for ೧೭೯ નિર્ડ PART THE ORAL HYSIENE DALLY TO OF FROM THE SURFACE PLAQUE REMOVE TONGUE Of THE
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rummer
(Division Sign-Off) Division of Dental, Infection Control and General Hosp 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Image /page/3/Picture/9 description: The image shows a circle with the letter 'S' inside. The circle is drawn with a thick black line, and the letter 'S' is also in black. The letter 'S' is a simple, sans-serif style. The background is plain white.
(Optional Format 1-2-96)