(77 days)
Not Found
No
The device description and performance studies focus on the material and design of a simple mechanical device, with no mention of AI or ML.
No
The device is described as a tongue cleaner intended for improved oral hygiene by removing bacteria and food debris, which is not considered a therapeutic function. Therapeutic devices are typically defined as those that treat or prevent disease, or affect the structure or function of the body, which simply removing surface debris does not qualify as.
No
Explanation: The device's intended use is to remove bacteria and food debris, promoting oral hygiene. It does not diagnose any condition or disease.
No
The device description explicitly states it is a "U-formed design made of Copper," indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Copper Tongue Scraper's intended use is to physically remove bacteria and food debris from the tongue surface. It does not involve testing a sample from the body to diagnose or monitor a condition.
- Intended Use/Indications for Use: The description clearly states its purpose is for "promoting good oral hygiene" by removing physical matter.
- Device Description: It's a physical tool made of copper.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
Therefore, based on the provided information, the Copper Tongue Scraper is a physical oral hygiene device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Copper Tongue Scraper's intend use is to remove bacteria and food debris from the tongue surface, hence promoting good oral hygiene. It is intended for over-the-counter point of sale as are other predicate devices.
Product codes
LCN
Device Description
This device is a U-formed design made of Copper.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tongue surface
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
The Copper Tongue Scraper's effectiveness is based on the long history of safe use of tongue scrapers. The Copper Tongue Scraper has the same design principals as the predicate devices. The only difference is that Copper Tongue Scraper is made from copper. Based on the characteristics and health benefits of copper, it is a safe material to use for this device. Therefore the Copper Tongue Scraper is substantially equivalent to the predicate devices because it raises no additional issues of safety and effectiveness.
Key Metrics
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
MAY 20 1998
510(k) Summary
Submitter: Ontel Products Corporation 2 Daniel Road East Fairfield, NJ 07004
Contact person: Mike K. Lakhiani
2 Daniel Road East Fairfield, NJ 07004 Phone: 973-227-6400 Phone: 800-245-0511 973-227-8820 Fax:
Date Prepared: March 2nd, 1998
Name of Device: Copper Tongue Scraper
Common/Usual Name: Tongue Scraper / Tongue Cleaner
Classification Name: Scraper, Tongue (per 76LCN)
Predicate Device: U.S. Dentek Sakool (K961574) Ooli-U Tongue Scraper (K970042)
Description of Device: This device is a U-formed design made of Copper.
Intended Use: This device is used to effectively remove bacteria and food debris from the surface of the tongue.
1
510(k) Summary
Technological Characteristics: The Copper Tongue Scraper and the mentioned predicate devices all work in a similar fashion. They are all manual devices used to remove bacteria and food debris from the surface of the tongue by a gentle forward scraping motion. The Copper Tongue Scraper is composed of copper. Copper is biostatic, which means bacteria will not grow on its surface.
Summary to support substantial equivalence: The Copper Tongue Scraper's effectiveness is based on the long history of safe use of tongue scrapers. The Copper Tongue Scraper has the same design principals as the predicate devices. The only difference is that Copper Tongue Scraper is made from copper. Based on the characteristics and health benefits of copper, it is a safe material to use for this device. Therefore the Copper Tongue Scraper is substantially equivalent to the predicate devices because it raises no additional issues of safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 20 1998
Mr. Mike K. Lakhiani ·Vice President of Sales Ontel Products Corporation 2 Daniel Road East Fairfield, New Jersey 07004
Re : K980842 Copper Tongue Scraper Trade Name: Regulatory Class: Unclassified Product Code: LCN Dated: March 2, 1998 Received: March 4, 1998
Dear Mr. Lakhiani:
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 legally marketed predicate 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. A. - - --substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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
3
Page 2 - Mr. Lakhiani
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 (301) 594-4692. 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 ere regulation enereica) 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.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: COPPER TONGUE SCRAPER
Indications For Use:
Copper Tongue Scraper's intend use is to remove bacteria and food debris from the tongue surface, hence promoting good It is intended for over-the-counter point of oral hygiene. sale as are other predicate devices.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rannes
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)