Pulpdent VARNISH I, II, III, and IV are desensitizing cavity varnishes and dentinal tubule sealers. They are indicated for exposed sensitive dentin or cementum after scaling, prophylaxis, cavity preparation and prior to any cementation and pin or post seating. Pulpdent VARNISH forms a hard protective coating which protects dentin and pulp, reduces acid diffusion from cements, minimizes marginal leaks and acts as a thermal insulator. This coating controls dentinal fluid flow by sealing the dentinal tubules and producing a physiologic barrier. Pulpdent VARNISH is used by the dental professional to control thermal shock and sensitivity in teeth undergoing treatment or restoration. It can be applied to all prepared cavities, to dentin and enamel, with or without the smear layer removed. Pulpdent VARNISH can be used under veneers, inlays, crowns, onlays, amalgams and composite resins and to treat cervical or root sensitivity.

Device Description

Pulpdent VARNISH I, II, III and IV are mixtures of either copal resin or polyamide resin and strontium chloride in organic solvent. The formulas for Varnish III and IV also contain the surfactant, cetyl pyridinium chloride.

AI/ML Overview

This document is a 510(k) premarket notification for a dental device, "PULPDENT CAVITY VARNISH," submitted to the FDA in 1998. It does not include information about acceptance criteria or a study proving the device meets acceptance criteria in the way a modern AI/software device submission would. Instead, it relies on the concept of "substantial equivalence" to predicate devices.

Therefore, for aspects of your request that pertain to modern AI/software device evaluation (like sample sizes for test/training sets, expert ground truthing, MRMC studies, or standalone performance), the document provides no relevant information.

Here's how the available information maps to your request:

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

This document describes safety and effectiveness in terms of historical use and substantial equivalence, not specific quantitative acceptance criteria or performance metrics derived from a study.

Acceptance Criteria	Reported Device Performance
Safety:	"effective and safe over about twenty years of experience"
"no evidence of short or long term risk or suspicion of any problems after literally billions of procedures in the United States."
Effectiveness:	Defined by meeting the intended use as a "desensitizing cavity varnish and dentinal tubule sealer" with functions like protecting dentin/pulp, reducing acid diffusion, minimizing marginal leaks, acting as a thermal insulator, and controlling dentinal fluid flow.
Supported by reference to "scientific and clinical literature" and "substantial equivalence" to predicate devices.

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

No test set or associated data provenance is described. The submission relies on "substantial equivalence" and historical literature.

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 applicable. No ground truth establishment for a test set is described.

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

Not applicable. No test set adjudication is described.

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 non-AI dental varnish, and no MRMC study was conducted.

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

Not applicable. This is a non-AI dental varnish.

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

The closest concept to "ground truth" here is the historical scientific and clinical literature, which provides evidence for the safety and effectiveness of cavity varnishes of similar composition over time, and the implicitly accepted "ground truth" that the predicate devices are safe and effective for their intended uses. This is a regulatory "ground truth" by precedent rather than a specific study's ground truth.

8. The sample size for the training set:

Not applicable. There is no training set for an algorithm described.

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

Not applicable. There is no training set or associated ground truth establishment described.

Summary

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PULPDENT CORPORATION

510 k PREMARKET NOTIFICATION: CAVITY VARNISH

EXHIBIT 2

FEB | 8 1998

RESPONSE TO SMDA OF 1990

SUMMARY OF SAFETY AND EFFECTIVENESS DATA

Kenneth J. Berk 80 Oakland Street PO Box 780 Watertown, MA 02272-0780 USA TELEPHONE: (617) 926-6666 (617) 926-6262 FAX:

DEVICE NAME:

PREDICATE DEVICES:

Pulpdent VARNISH I, II. III. IV

Pulpdent Polyamide Dentin Liner Pulpdent Copal Varnish Cetylite Zarosen Cooley & Cooley Copalite Varnish

DESCRIPTION AND INTENDED USE:

Pulpdent VARNISH I, II, III, IV are desensitizing cavity varnishes and dentinal tubule sealers, They are indicated for exposed sensitive dentin or cementum after scaling, prophylaxis, cavity preparation and prior to any cementation and pin or post seating. Pulpdent VARNISH forms a hard protective coating which protects dentin and pulp, reduces acid diffusion from cements. minimizes marginal leaks and acts as a thermal insulator. This coating controls dentinal fluid flow by sealing the dentinal tubules and producing a physiologic barrier. It can be applied to all prepared cavities, to dentin and enamel, with or without the smear layer removed.

Pulpdent VARNISH is used by the dental professional to control thermal shock and sensitivity in teeth undergoing treatment or restoration. It can be used under veneers, inlays, crowns, onlays, amalgams and composite resins and to treat cervical or root sensitivity. Pulpdent VARNISH is a mixture of either copal resin or polyamide resin and strontium chloride in organic solvent. Formulas for Pulpdent Vamish III and IV also contain the surfactant cetyl pyridinium chlonde.

COMPARISON WITH PREDICATE PRODUCTS:

Pulpdent VARNISH is substantially equivalent in composition and intended use to the predicate products. Please see Exhibit 4 for the entire comparison.

SAFETY AND EFFECTIVENESS:

According to the scientific and clinical literature, use of cavity varnishes made from the materials present in Pulpdent Varnish have been effective and safe over about twenty years of experience. There is no evidence of short or long term risk or suspicion of any problems after literally billions of procedures in the United States. Please see Exhibit 8 for representative references.

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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 & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 8 1998

Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street 02272-0780 Watertown, Massachusetts

Re : K974398 Trade Name: Pulpdent Cavity Varnish Regulatory Class: II Product Code: ГВН Dated: November 17, 1997 Received: November 21, 1997

Dear Mr. Berk:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with ... the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Berk

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timot A. Ulatowski Directdr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 ol 1

5 1 O(k) Number (il known):

Device Name: PULPDENT CAVITY VARNISH

Indications I-or Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Susan Purser
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K974138

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use
------------------------------------------	----	----------------------

(Optional Format 1-2-96)

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.