The UltraEZ Desensitizing Gel provides a film-like varnish for sensitive teeth, sealing dentinal tubules of over exposed dentin and other exposed areas where post-operative or other dentin sensitivity is a concern. The product is used either by a dental professional in the dental office or provided to the patient for home treatment of dentin sensitivity.

Device Description

Composed of potassium nitrate and fluoride ions in a film-like varnish. 3% Potassium Nitrate and 0.11% w/w Fluoride Ion Gel for the treatment of dentin sensitivity. For professional dental use. Immediate physical blockage of dentinal tubules to eliminate painful sensitivity. Designed to be used in a custom-fabricated dental tray.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "UltraEZ Desensitizing Gel." This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical analysis.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, sample size for training set) are not applicable in this context because the submission is not a typical performance study as you might find for a diagnostic or AI-driven device.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly that the new device is as safe and effective as the predicate devices. The "performance" is demonstrated by showing similar composition and intended use.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (UltraEZ Desensitizing Gel)
Composition: Contains potassium nitrate and fluoride ions in a film-like varnish.	Composed of potassium nitrate and fluoride ions in a film-like varnish. (Matches predicates)
Potassium Nitrate & Fluoride Concentration: Similar concentrations to predicate devices.	3% Potassium Nitrate and 0.11% w/w Fluoride Ion Gel. (Comparable to predicate's 3% Potassium Nitrate and 1200 ppm Fluoride Ion Gel, though exact numerical equivalence isn't stated for fluoride, it's considered functionally similar for efficacy.)
Intended Use: For professional dental use for treatment of dentin sensitivity.	For professional dental use for the treatment of dentin sensitivity. (Matches predicates)
Mechanism of Action: Provides immediate physical blockage of dentinal tubules to eliminate painful sensitivity.	Immediate physical blockage of dentinal tubules to eliminate painful sensitivity. (Matches predicates)
Indications for Use: Provides a film-like varnish for sensitive teeth, sealing dentinal tubules of over-exposed dentin and other exposed areas where post-operative or other dentin sensitivity is a concern. Used by dental professionals or for home treatment.	The UltraEZ Desensitizing Gel provides a film-like varnish... (Matches stated indications for use, which are consistent with predicate's function.)

2. Sample size used for the test set and the data provenance

Not Applicable. This submission relies on a comparison table of product characteristics with legally marketed predicate devices, not on a clinical test set. No data provenance is specified as a clinical study was not conducted or reported here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. No ground truth was established by experts for a test set in this substantial equivalence submission. The "ground truth" is essentially the established safety and efficacy of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set or adjudication method was used for this type of submission.

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

This is Not Applicable. This device is a dental product (desensitizing gel) and not an AI-driven or diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in a substantial equivalence filing is implied to be the established safety and effectiveness of the legally marketed predicate devices. The submission argues that because the new device is essentially the same in composition, indications, and mechanism as previously cleared devices, it also shares their safety and efficacy profile. No new ground truth data from clinical trials is typically required or presented for such filings unless safety or effectiveness questions are raised by the differences.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device; therefore, there is no training set.

9. How the ground truth for the training set was established

Not Applicable. There is no training set as it's not an AI/machine learning device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Ultradent Products, Inc. The logo consists of a stylized "U" shape on the left, followed by the word "ULTRADENT" in bold, uppercase letters. Below "ULTRADENT" is the phrase "PRODUCTS, INC." in a smaller, thinner font. The overall design is simple and professional, conveying a sense of reliability and innovation.

K061438

SUMMARY REPORT AND STATEMENT OF COMPARISON

INTRODUCTION:

This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92 and supports the conclusion of SE for UltraEZ Desensitizing Gel noted below.

1. Applicant's Name and Address:

Ultradent Products, Inc. 505 West 10200 South South Jordan, Utah 84095 Telephone number: 801-553-4323 Fax number: 801-572-0600 Contact Person: Tammy Lavery Regulatory Affairs Senior Manager

Device Information: 2.

Classification:	Class II
Regulation:	872.3260
Trade Name:	UltraEZ Desensitizing Gel
Common Name:	Tooth Desensitizer
Classification Name:	Varnish, Cavity
Classification Code:	LBH
Classification Panel:	Dental

3. Indications for Use:

4. Predicate Device Description & Statement of Comparison to Predicate Device:

UltraEZ Desensitizing Gel which is to be manufactured and marketed by Ultradent Products, Inc., 505 West 10200 South, South Jordan, Utah 84095, is substantially equivalent to the legally - marketed device(s): Cosmedent Tooth Desensitizer marketed by Cosmedent, Inc., 401 N. Michegan Avenue, Ste 2500, Chicago, IL 60611, and Protect marketed by Sunstar Butler Refer, 4635 West Foster Avenue, Chicago, IL 60630. Refer to the comparison table below.

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Image /page/1/Picture/0 description: The image shows the logo for Ultradent Products, Inc. The logo features a stylized "U" and "E" combined into a single graphic on the left. To the right of the graphic is the word "ULTRADENT" in bold, sans-serif font. Below "ULTRADENT" is the phrase "PRODUCTS, INC." in a smaller, sans-serif font.

Product Description Similarities:

UltraEZ Desensitizing Gel	Cosmedent Desensitizing Gel	Protect Desensitizing Gel
Composed of potassium nitrateand fluoride ions in a film-likevarnish.	Composed of potassium nitrateand fluoride ions in a film-likevarnish.	Composed of potassium andfluoride ions in a film-like varnish.
3% Potassium Nitrate and 0.11%w/w Fluoride Ion Gel for thetreatment of dentin sensitivity.	3% Potassium Nitrate and 1200ppm Fluoride Ion Gel for thetreatment of dentin sensitivity.	Ingredients: Ethanol, water,hydroxypropylcellulose, potassiumfluoride, polyethylene glycol,dimethacrylate, methacrylates.
For professional dental use.	For professional dental use.	For professional dental use.
Immediate physical blockage ofdentinal tubules to eliminatepainful sensitivity.	Immediate physical blockage ofdentinal tubules to eliminatepainful sensitivity.	Immediate physical blockage ofdentinal tubules to eliminatepainful sensitivity.

Product Description Differences:

UltraEZ Desensitizing Gel	Cosmedent Desensitizing Gel	Protect Desensitizing Gel
Designed to be used in a custom-fabricated dental tray.	Designed to be tray delivered ormay be brushed directly on theaffected area:	Designed to be brushed directly onthe affected area.

CONCLUSION:

Ultradent deems the UltraEZ Desensitizing Gel to be substantially equivalent and equally safe and effective as that of the predicates: Cosmedent's Tooth Desensitizer and Sunstar Butler's Protect Tooth Desensitizer per comparison noted above.

Tammy Lavery

Tammy Laver Regulatory Affairs Senior Manager Submitter and Contact 800 552-5512 extension 4323 or direct 801 553-4323 fax 801 553-4609 or 801 572-0600 email: Itamara@ultradent.com

Aug 7, 2006
Date

Page 2 of 2

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Tammy Lavery Regulatory Affairs Senior Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095

JUN 1 2 2007

Re: K061438

Trade/Device Name: UltraEZ Desensitizing Gel Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: June 8, 2007 Received: June 11, 2007

Dear Ms. Lavery:

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 - Ms. Lavery

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.

Susan Gunner

O 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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Page 1 of 1

INDICATIONS FOR USE

510(k) Number (if known): Unknown

Device Name: UltraEZ Desensitizing Gel

Indications for use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: X (Per 21 CFR 801.109)

Over-The-Counter Use:_

(Optional Format 1-2-96)

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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.