Enamelast™ Fluoride Varnish is 5% sodium fluoride in a varnish carrier which produces a mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.

Device Description

Enamelast Fluoride Varnish is a flavored, xylitol-sweetened 5% sodium fluoride in a resin carrier delivered in a 0.4mL unit dose blister pack or in a 1.2mL syringe. Applicator brushes are provided with the 0.4mL unit dose blister. Delivery mechanisms are recommended in the instructions for use.

AI/ML Overview

This document is a 510(k) Summary for a medical device called Enamelast™, a fluoride varnish. It aims to demonstrate substantial equivalence to a predicate device, Flor-Opal Varnish White.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving device performance:

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

The document does not explicitly present a table of "acceptance criteria" for the device, but rather a "Substantial equivalence comparison" table (Table 7-1) that compares the characteristics of Enamelast™ with a predicate device (Flor-Opal Varnish White). This comparison implicitly serves to demonstrate that Enamelast™ meets performance standards similar to a legally marketed device.

Here's a reinterpretation of Table 7-1, focusing on characteristics that could be considered performance indicators:

Characteristic	Acceptance Criteria (Implied by Predicate - Flor-Opal Varnish White)	Reported Device Performance (Enamelast™)
Intended Use	Treatment of tooth hypersensitivity via 5% sodium fluoride in varnish, mechanical/chemical occlusion of dentinal tubules.	Treatment of tooth hypersensitivity via 5% sodium fluoride in varnish, mechanical occlusion of dentinal tubules.
Intended User	Dental professional	Dental professional
Chemical Char.	5% sodium fluoride, Resin based	5% sodium fluoride, Resin based
Delivery System	Syringe-to-syringe mixing system with applicator tip	1.2 mL pre-filled syringe; 0.4mL unit dose blister pack with applicator brush
Appearance	White resinous material	White resinous material
Odor	Bubble gum or Mint	Mint or Walterberry (strawberry/amaretto)
pH (Mint)	2.95	3.9
Shelf Life	18 months	24 months
Biocompatibility	Cytotoxicity (tested)	Cytotoxicity, Oral Mucosa Irritation, Genotoxicity, Sensitization (all tested)
Functional Testing	Film Thickness (tested)	Fluoride uptake, Fluoride varnish retention, Film Thickness (all tested)

The document states, "The data supports the functionality of Enamelast." and "In summary, this submission demonstrates that Enamelast is substantially equivalent in safety and effectiveness and performs equivalently or better to the identified predicate and comparable product for its intended use."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "In-house comparison testing has been performed on Enamelast, the predicate device, Flor-Opal Varnish White and OT Varnish 5% NaF." However, it does not provide any specific sample sizes for this testing.

The data provenance is stated as "In-house comparison testing," suggesting the tests were conducted by Ultradent Products, Inc. No information is given about the country of origin of the data or whether it was retrospective or prospective.

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)

This section is not applicable as the document describes a chemical/physical dental product, not an AI/diagnostic device that would require expert-established ground truth for a test set. The "ground truth" here would be the measured physical and chemical properties and biocompatibility results.

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

This is not applicable for the type of device and testing described. Adjudication methods like "2+1" typically apply to image interpretation or clinical diagnosis where multiple experts evaluate a case and resolve discrepancies. The testing described involves laboratory measurements of material properties and biocompatibility.

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. The device is a fluoride varnish, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance would not be relevant.

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

This is not applicable. The device is a physical product (fluoride varnish), not an algorithm or AI system.

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

The ground truth for this device's performance would be derived from:

Physical and Chemical Testing: Direct measurements of properties like pH, film thickness, fluoride uptake, and varnish retention.
Biocompatibility Testing: Laboratory assays (e.g., cytotoxicity, oral mucosa irritation, genotoxicity, sensitization) according to established standards.

8. The sample size for the training set

This is not applicable. The device is a physical product, not a machine learning model that would require a "training set."

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

This is not applicable for the reasons stated in point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a stylized logo in black. The logo appears to be a combination of the letters 'U' and 'R' in a bold, blocky font. The 'U' is on the left, and the 'R' is formed by a vertical line extending from the top of the 'U' and a horizontal line extending from the middle of the 'U'. There is a small circle in the upper right corner of the logo.

Section 7: 510(k) Summary

This summary of the 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92.

l. Applicant's Name and Address

Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095

NOV 0 1 2013

Contact Person:	Karen Kakunes, RN
Title:	Sr. Regulatory Affairs Associate
Telephone:	800-552-5512 x4366, 801-553-4366
FAX:	801-553-4609
Date Summary Prepared:	28 June 2013

11. Name of the Device

Trade Name:	Enamelast™
Common Name:	Cavity Varnish
Device Classification:	Class II
Classification Product Code:	LBH
Regulation No.	CFR 872.3260

III. Device Description:

IV. Statement of intended use:

Enamelast™Fluoride Varnish is 5% sodium fluoride in a varnish carrier which produces a mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a stylized logo in black against a white background. The logo appears to be a monogram, possibly representing two letters or initials that are interconnected. The design is geometric with rounded corners, giving it a modern and abstract look. A small superscript letter 'G' is positioned at the upper right corner of the logo.

Comparison of technological characteristics V.

Table 7-1: Substantial equivalence comparison

Characteristic	Comparison Product
	(Flor-Opal Varnish White K080249)	Enamelast™
Intended Use	Flor-Opal Varnish White is 5% sodiumfluoride in a varnish carrier whichproduces a mechanical/chemicalocclusion of the dentinal tubules inthe treatment of toothhypersensitivity.	Enamelast™ Fluoride Varnish is 5% sodiumfluoride in a varnish carrier which produces amechanical occlusion of the dentinal tubules inthe treatment of tooth hypersensitivity.
Intended user	Dental professional	Dental professional
ChemicalCharacteristics	5% sodium fluorideResin based	5% sodium fluorideResin based
Delivery system	Syringe-to-syringe mixing system withapplicator tip	1.2 mL pre-filled syringe ; 0.4mL unit doseblister pack with applicator brush
Physical properties	Appearance: White resinous materialOdor: Bubble gum or Mint	Appearance: A white resinous material Odor:Mint or Walterberry (strawberry/amaretto)
	pH: Mint - 2.95	pH: Mint - 3.9; Walterberry - 3.9
	Shelf Life: 18 months	Shelf Life: 24 months
Biocompatibility	Cytotoxicity	CytotoxicityOral Mucosa IrritationGenotoxicitySensitization
Functional Testing	Film Thickness	Fluoride uptakeFluoride varnish retentionFilm Thickness

Enamelast is a similar material used in the same way by the same types of users as the identified predicate device Flor-Opal Varnish White, introducing no new major safety or efficacy questions.

Image /page/1/Picture/5 description: The image shows the logo for Ultradent Products, Inc. The logo is in black and white and features the company name in a bold, sans-serif font. The word "ULTRADENT" is on the top line, and "PRODUCTS, INC." is on the bottom line. The logo is simple and professional.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a stylized logo with two blocky, interconnected shapes. The shape on the left resembles a 'U', while the shape on the right resembles a 'P'. The shapes are bold and solid, with rounded corners, giving the logo a modern and geometric appearance. A small trademark symbol is visible in the upper right corner of the logo.

Biocompatibility testing shows that the product is safe when used as instructed by a dental professional. In-house comparison testing has been performed on Enamelast, the predicate device, Flor-Opal Varnish White and OT Varnish 5% NaF. The data supports the functionality of Enamelast.

In summary, this submission demonstrates that Enamelast is substantially equivalent in safety and effectiveness and performs equivalently or better to the identified predicate and comparable product for its intended use.

Image /page/2/Picture/4 description: The image shows the logo for Ultradent Products, Inc. The logo is in black and white and features the company name in a bold, sans-serif font. The letters 'UP' are stacked on top of each other on the left side of the logo. The words 'PRODUCTS, INC.' are written in a smaller font below the company name.

W.U.STACTERN 800 - 57 45

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 1, 2013

Ultradent Products, Incorporated Ms. Karen Kakunes Senior Regulatory Affairs Associate 505 West 10200 South South Jordan, UT 84095

Re: K132109

Trade/Device Name: Enamelast™ Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: July 17, 2013 Received: July 24, 2013

Dear Ms Kakunes:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{4}------------------------------------------------

Page 2 - Ms. Kakunes

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

MarySBunner-S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

{5}------------------------------------------------

Section 6: Statement of Indications for Use

510(k) Number (if known): K132109

Device Name: Enamelast™

Indications for Use: Enamelast™ Fluoride Varnish is 5% sodium fluoride in a varnish carrier which produces a mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.

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)

Page 1 of 1

Andrer

(Posted November 13, 2003)

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.