Activ Varnish is a resin-based varnish, containing 17% Xylitol and less than 20% ethanol, that is applied to enamel or dentin for professional treatment of dental hypersensitivity. Activ Varnish treats hypersensitivity by releasing fluoride, calcium and phosphorus ions that precipitate on and, thereby, occlude dentinal tubules and fill superficial, non-carious enamel lesions.

Device Description

Activ Varnish is a resin-based varnish, containing 17% Xyliol and less than 20% ethanol, that is applied to enamel or dentin for professional treatment of dental hypersensitivity. Activ Varnish treats hypersensitivity by releasing fluoride, calcium and phosphorus ions that precipitate on and, thereby, occlude dentinal tubules and fill superficial, non-carious enamel lesions. Activ Vamish is available in unit-dose and bulk packaging.

AI/ML Overview

This submission is a 510(k) premarket notification for a dental varnish. 510(k)s demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with acceptance criteria. Therefore, the information typically requested regarding acceptance criteria and detailed study specifications is not present in this document.

Here's a breakdown of the available information regarding "safety and effectiveness" as presented in this 510(k) summary:

The document states:
"SAFETY AND EFFECTIVENESS: Activ Varnish is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above that have been on the market and used successfully by dental professionals for more than 15 years with no serious safety or effectiveness problems."

Based on this statement, there is no specific study described that proves the device meets explicit acceptance criteria in the manner of a clinical trial. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices that have a long history of safe and effective use.

Here's why the specific points you requested are not applicable or cannot be answered from this 510(k) submission:

A table of acceptance criteria and the reported device performance: Not applicable. There is no such table because this is a substantial equivalence claim, not a new clinical study with predefined acceptance criteria. The "performance" is considered equivalent to the predicate devices.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set or clinical data is presented for Activ Varnish to demonstrate performance against specific criteria. The safety and effectiveness are inferred from the predicate devices' history.
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 applicable. No test set, no ground truth establishment in this context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 dental material, not an AI or imaging device involving human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a dental material, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for the substantial equivalence claim resides in the predicate devices' established safety and effectiveness over 15+ years.
The sample size for the training set: Not applicable. This is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

In summary: The document establishes the safety and effectiveness of Activ Varnish by asserting its substantial equivalence to existing, legally marketed predicate devices with a proven track record of safe and effective use over many years. This type of submission relies on comparisons of design, composition, performance, and intended use, rather than de novo clinical studies with specific performance metrics and acceptance criteria.

Summary

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R11294

EXHIBIT 2

DEC - 9 2011

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA

Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02472 USA

DEVICE

Trade Name: Activ Varnish Class: Il

Telephone: 617-926-6666 617-926-6262 Fax: ken@pulpdent.com

Classification Name: Cavity Varnish FDA Product Code: 76LBH, 21 CFR Part 872.3260

PREDICATE DEVICES:

Pulpdent Fluoride Varnish Ultradent Flor-Opal Vamish White 3M Vanish 5% NaF White Vamish Colgate Duraphat Voco ReminPro

DESCRIPTION AND INTENDED USE:

Activ Vamish is a resin-based varnish, containing 17% Xyliol and less than 20% ethanol, that is applied to enamel or dentin for professional treatment of dental hypersensitivity. Activ Varnish treats hypersensitivity by releasing fluoride, calcium and phosphorus ions that precipitate on and, thereby, occlude dentinal tubules and fill superficial, non-carious enamel lesions. Activ Vamish is available in unit-dose and bulk packaging.

COMPARISON WITH PREDICATE PRODUCTS:

Activ Varnish is substantially equivalent in design, composition, performance, and intended use to the predicate products:

Product	510(k) Number	Description	Intended Use	Composition
Pulpdent Activ Varnish		Resin-based fluoridevarnish	To treat toothhypersensitivity	Resin, Ethyl alcohol, Xylitol,Sodium fluoride, Calcium andPhosphate salts, Flavorant.
Pulpdent Fluoride Varnish	K093620	Resin-based fluoridevarnish	To treat toothhypersensitivity	Rosin, Ethyl lactate FCC, Sodiumfluoride, Flavorant
UltradentFlor-Opal Varnish White	K080249	5% sodium fluoride in aresin carrier	To treat toothhypersensitivity	Natural resin, Alcohol, Xylitol
3M Vanish5% NaF White Varnish	K880741	Resin-based fluoridevarnish	To treat toothhypersensitivity	Rosin ester, n-Hexane, Ethylalcohol, Sodium fluoride,Thickener, Flavor and Color
Colgate Duraphat	K945794	Rosin-based fluoridevarnish	To treat toothhypersensitivity.	Rosin, Ethyl alcohol, Sodiumfluoride, Water, Flavorant
Voco ReminPro	K101104	Hydroxyapatite andfluoride paste	Prevention andcontrol ofhypersensitivity	Calcium phosphate, Sodiumfluoride, Xylitol

SAFETY AND EFFECTIVENESS:

Activ Vamish is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above that have been on the market and used successfully by dental professionals for more than 15 years with no serious safety or effectiveness problems.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street P.O. Box 780 Watertown, Masachussets 02472

Re: K112946

Trade/Device Name: Pulpdent Activ Varnish Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: September 29, 2011 Received: October 6, 2011

Dear Mr. Berk:

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.

DEC - 9 2011

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Page 2 – Mr. Berk

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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,

Anthony V. Amato

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use

510(k) Number (if known): K | | 2 946

Device Name: Pulpdent Activ Varnish

Indications For Use:

Prescription Use X (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 Kuener

(Division Sign-Off) (Division of Anesthesiology. General Hospital Infection Control, Dental Devices

Page 1 of 1

510(k) Number: K112946

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.