(119 days)
The product is used either by a dental professional in the dental office or by a patient at home to treat dentin sensitivity.
Cosmedent TOOTH DESENSITIZER is a 3% potassium nitrate and 1200 ppm fluoride ion gel desensitizer. The indication for this product is tooth discomfort caused by dentine sensitivity. TOOTH DESENSITIZER is a gel desensitizer device based on the well documented effects of potassium nitrate and fluoride ion on dentine sensitivity due to patent dentinal tubules. TOOTH DESENSITIZER is available as a clear, green-colored, gel. It can be used either by gently brushing the affected area with the product or it can be used in a custom tray.
The provided text is a 510(k) premarket notification for a tooth desensitizer. It details the device's description, intended use, and comparison to a legally marketed predicate device.
However, the document does not contain any information regarding clinical studies, performance data, acceptance criteria, sample sizes (for test or training sets), expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.
The 510(k) summary (from document {0}) states: "TOOTH DESENSITIZER is a gel desensitizer device based on the well documented effects of potassium nitrate and fluoride ion on dentine sensitivity due to patent dentinal tubules." This implies that the device's effectiveness relies on the known mechanisms of its active ingredients, rather than new clinical trials specifically for this product to prove novel efficacy beyond what is already established for these ingredients.
Therefore, I cannot populate the table or answer most of the questions you've posed, as the necessary information is not present in the provided text.
Here is what can be inferred or stated from the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the document.
- Reported Device Performance: Not specified as quantitative performance metrics. The document states it is "based on the well documented effects of potassium nitrate and fluoride ion on dentine sensitivity," suggesting reliance on established scientific literature for its active ingredients rather than new performance data.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. No test set data appears to have been presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified. No ground truth establishment for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified. No test set adjudication is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a medical device (tooth desensitizer), not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (tooth desensitizer), not an AI/imaging device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified directly. The submission relies on "well documented effects of potassium nitrate and fluoride ion on dentine sensitivity," implying that the ground truth for their efficacy is based on existing scientific and clinical understanding of these active ingredients.
8. The sample size for the training set
- Not applicable. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. No training set is mentioned.
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K 052263
Cosmedent, Inc. 401 N. Michigan Ave., Ste 2500, Chicago, IL 60611 Page 13 of 15 510(k) submission for TOOTH DESENSITIZER
510(k) SUMMARY
As required by the Safe Medical Devices Act of 1990
IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICES
Ultradent UltraEZ is a 3% potassium nitrate and 0.11% fluoride ion gel desensitizer. The indication for this product is the relief of tooth discomfort caused by root sensitivity, thermal and chemical changes, periodontal conditions ... etc.
DESCRIPTION OF THE APPLICANT DEVICE – TOOTH DESENSITIZER
Cosmedent TOOTH DESENSITIZER is a 3% potassium nitrate and 1200 ppm fluoride ion gel desensitizer. The indication for this product is tooth discomfort caused by dentine sensitivity.
TOOTH DESENSITIZER is a gel desensitizer device based on the well documented effects of potassium nitrate and fluoride ion on dentine sensitivity due to patent dentinal tubules.
TOOTH DESENSITIZER is available as a clear, green-colored, gel. It can be used either by gently brushing the affected area with the product or it can be used in a custom tray.
INTENDED USES OF THE APPLICANT DEVICE
TOOTH DESENSITIZER is intended to be used to relieve the discomfort from dentin sensitivity.
Jamish. Sandik
Janes L. Sandrik, PhD
Cosmedent, Inc. 401 N. Michigan Avenue Suite 2500 Chicago, Illinois 60611 Submitted: August 16, 2005
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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 eagle with three lines forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 16 2005
Mr. James L. Sandrik Director of Regulatory Affairs Cosmedent, Incorporated 401 North Michigan Avenue, Suite 2500 Chicago, Illinois 60611
Re: K052263
Trade/Device Name: Multiple (Tooth Desensitizer) Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: December 14, 2005 Received: December 15, 2005
Dear Mr. Sandrik:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section 970(t) proceeded is substantially equivalent (for the referenced above and have determined the actively marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate commerce prior to rita - 20, 1978, 1978, 1978, 1978, 1998, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 19 Allendinents, of to devrees that have eet (Act) that do not require approval of a premarket the rederal Pood, Drug, and Oosmette 1.00 may, therefore, market the device, subject to the general approval application (1 Mr.). * The general controls provisions of the Act include controls provisions of the rica - 110 , 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 II your device is classified (see above) into controls. Existing major regulations affecting (PMA), it may of Subject to Such adam adamal Regulations, Title 21, Paris 800 to 898. In your device can be found in the South I vectoring your device in the Federal Register.
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Page 2 - Mr. Sandrik
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DX 3 issualled on that your device complies with other requirements mean that I DA nas made a decemblations administered by other Federal agencies. of the Act of ally rederal statutes and regarations, but not limited to: registration You must comply with an the Fee b requirements) (1); good manufacturing practice and listing (21 CFR Pat 607), laooling (21 CFR Part 820) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 12 requirements as set form in the quality of oversions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mailoring your substantial equivalence of your device to a premiarket notification. The PDF matts 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), If you desire specific advice for your de 100 - 100 - 100 - 100 - 100 - 100 - 100 - 200 - 000 - 000 - 000 - 000 - 000 - 000 - 000 - 000 - 000 - 000 - 000 - 000 - 000 - 000 prease contact the Other or other man premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general micrimational and Consumer Assistance at its toll-free Division of Driaa 2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Cals
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name: MULTIPLE (TOOTH DESENSITIZER)
Indications For Use:
- The product is used either by a dental professional in the dental office or by a . patient at home to treat dentin sensitivity.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runnes
on of Anesthellology, General Hospital, Ston Control, Dental Devices
) Number KC52263
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.