DenShield™ is intended for the rapid and continual relief of hypersensitivity associated with exposed tooth dentin. Studies have shown that Dentibitly is effective at occluding exposed dentinal tubules, which has been showmin the literature to be associated with a reduction in hypersensitivity.

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for a dental device, DenShield™ Treatment for Sensitive Teeth, which is a cavity varnish. The document primarily focuses on regulatory approval and equivalence to predicate devices, rather than detailed performance studies or AI incorporation.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and AI performance is not available within the provided text.

Here's why and what information can be extracted:

Information NOT available in the provided text:

A table of acceptance criteria and the reported device performance: The document states "Studies have shown that Dentibitly is effective at occluding exposed dentinal tubules..." but does not provide specific performance metrics or acceptance criteria.
Sample sized used for the test set and the data provenance: No details on study sample size or origin are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
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: This device is a cavity varnish, not an AI-powered diagnostic tool. This type of study is irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: While "occluding exposed dentinal tubules" is mentioned as a mechanism for effectiveness, the specific ground truth for the "studies" is not described.
The sample size for the training set: Not applicable for this type of device.
How the ground truth for the training set was established: Not applicable for this type of device.

Information that can be extracted or inferred:

Device Name: DenShield™ Treatment for Sensitive Teeth
Device Type: Cavity Varnish
Intended Use: Rapid and continual relief of hypersensitivity associated with exposed tooth dentin.
Mechanism of Action (as stated): Effective at occluding exposed dentinal tubules.
Regulatory Classification: Class II, Product Code: LBH, Regulation Number: 21 CFR 872.3260 (Cavity Varnish)
Regulatory Decision: Substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
Regulatory Body: Food and Drug Administration (FDA)
Date of Approval: October 18, 2006 (OC) 1 8 2006)

This document is a regulatory approval letter, generally not the place where detailed scientific study results are presented. Those would typically be found in the 510(k) submission itself or in published scientific literature.

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OC) 1 8 2006

David C. Greenspan, Ph.D. Vice President and Chief Technology Officer NovaMin Technology, Incorporated 13709 Progress Boulevard, Suite 23 Alachua, Florida 32615

Re: K061359

Trade/Device Name: DenShield™ Treatment for Sensitive Teeth Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class; II Product Code: LBH Dated: August 17, 2006 Received: August 17, 2006

Dear Dr. Greenspan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Greenspan

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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) 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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

Enclosure

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510(k) Number (if known):

Device Name: DenShield™ Treatment for Sensitive Teeth

Indications for Use:

Susan Conner

on Sign-Ciff) ാന of Anesthesiology, General Hospital, ction Control, Dental Devices 0 (01k) Number:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

SECTION C - INDICATIONS FOR USE STATEMENT

Regulation Number and Section

§ 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.