(86 days)
Not Found
No
The device description and intended use describe a simple mechanical tongue cleaner with no mention of AI or ML capabilities.
No.
The device is intended for mechanical cleaning and oral hygiene, not for treating or preventing specific diseases or conditions.
No
The device is described as a tongue cleaner intended to remove bacteria and plaque for oral hygiene, not to diagnose a condition or disease. Its function is purely for cleaning.
No
The device description explicitly states it is a physical device made of molded polypropylene plastic and stainless steel, with a handle and a U-shaped loop end. It does not mention any software components.
Based on the provided information, 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.
- Device Function: The Unik Tongue Cleaner is a physical device used to mechanically remove bacteria and plaque from the surface of the tongue. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use is focused on physical cleaning and promoting oral hygiene, not on diagnosing any condition through analysis of biological samples.
Therefore, the Unik Tongue Cleaner falls under the category of a general medical device for oral hygiene, not an IVD.
N/A
Intended Use / Indications for Use
The intended use of the Unik Tongue Cleaner is to remove bacteria from and prevent plaque build-up on the tongue to help fight bad breath and promote oral hygiene.
Product codes
LCN
Device Description
This is a device consisting of a molded polypropylene plastic handle, similar in appearance to that of a toothbrush, and a U-shaped loop end made of either polypropylene plastic or stainless steel. The device is used by placing the loop end at the back of the tongue The device is and gently dragging it toward the front. designed so that there are no sharp edges.
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
JAN 1 4 1999
510(K) SUMMARY
Submitter: 1.
Unik Products, Inc. Dr. Nathmal Tarfare, President 4786 Mount Vernon Blvd. Hamburg, New York 14075
Contact:
Harry E. Werner, Esq. Lipsitz, Green, et al. 42 Delaware Avenue Suite 300 Buffalo, New York 14202 Phone: (716) 849-1333 (ext. 397) (716) 855-1580 Fax :
Date prepared: October 16, 1998
2. Device Name:
- Trade Name: Unik Tongue Cleaner a.
- Common/Usual Name: Tongue Cleaner or Tongue Scraper 0.
- Classification Name: Scraper, Tongue (per LCN) C.
Predicate Device: 3.
- Breath-So-Fresh Tongue Cleaner (K972644) a .
Device Description: 4 .
This is a device consisting of a molded polypropylene plastic handle, similar in appearance to that of a toothbrush, and a U-shaped loop end made of either polypropylene plastic or stainless steel. The device is used by placing the loop end at the back of the tongue The device is and gently dragging it toward the front. designed so that there are no sharp edges.
Intended Use: 5 .
The intended use of the Unik Tongue Cleaner is to remove bacteria from and prevent plaque build-up on the tongue to help fight bad breath and promote oral hygiene.
4 - 1
1
Technological Characteristics: ୧.
The Unik Tongue Cleaner is similar to the Breath-So-Fresh The Unix Tongue Croaised in that both employ a handle at rongue creater (nop at the other end which is used to gently scrape the tongue. The Unik Tongue Cleaner's loop gencif beraped; the Breath-So-Fresh Tongue Cleaner's loop end is spoon shaped. The Breath-So-Fresh Tongue Cleaner is made entirely of plastic; the Unik Tongue Cleaner is made either of all plastic or a plastic handle with a stainless steel loop end.
The Unik Tongue Cleaner and the predicate device are used in the same fashion: the loop end of the device is placed on the back of the tongue and then gently dragged to the front of the tongue.
Summary to support substantial equivalence: 7.
The Unik Tongue Cleaner employs the same principles as the predicate device to accomplish the same end: use of a generally U-shaped loop to gently scrape bacteria and plaque from the surface of the tongue. Because the Unik praque Cleaner has the same intended use as the predicate device, is similar in design and is used in the same manner as the predicate device, it introduces no new or effectiveness issues and is therefore safety substantially equivalent to the predicate device.
2
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the right, resembling a bird-like shape.
JAN 29 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Unik Products, Incorporated C/O Harry E. Werner, Esq. Lipsitz, Green, et al. 42 Delaware Avnenue Suite 300 Buffalo, New York 14202
Re : K983683 Unik Tongue Cleaner Trade Name: Regulatory Class: Unclassified Product Code: LCN October 16, 1998 Dated: Received: October 20, 1998
Dear Mr. Werner:
This letter corrects our substantially equivalent letter of October 16, 1998 regarding the error that was made on the Statement of Indication for Use form.
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 You may, therefore, Food, Drug, and Cosmetic Act (Act). 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਮੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action.
3
Page 2 - Mr. Werner
In addition, the Food and Drug Administration (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 pbligation you might have under sections 531 through 542 of 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 ating 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 Additionally, for questions on Compliance at (301) 594-4692. the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note that 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 their toll free number (800) 638A2041 or at (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsmamain.html"
Sincerely
Timothy A. Ulatowski
Directfor
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): K983683
Device Name: Unik Tongue Cleaner
Indications for Use:
The intended use of the Unik Tongue Cleaner is to The intended use of the Unix fongue build-up on
remove bacteria from and prevent plaque build-in on remove bacteria from and prevent praque and of the follow oral hygiene.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K983683 |
| Prescription Use | OR | Over-The-Counter |
|---|---|---|
| Use (Per 21 CFR 801.109) |
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