Pulpdent Glaze II is a light-cured, unfilled resin that contains no Bisphenol A and is used as a penetrating composite sealer and bonding agent. Pulpdent Glaze II bonds to composite and etched enamel, seals composite margins, penetrates and seals composite surface, reducing micro-leakage, wear and marginal breakdown.

Device Description

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental device, PULPDENT GLAZE II. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials with detailed acceptance criteria and performance studies as might be seen for novel, higher-risk devices.

Here's an analysis of the provided text based on your request, highlighting what is (and isn't) present:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Substantial equivalence in design, composition, performance, intended use, safety, and effectiveness to predicate devices.	Stated to be "substantially equivalent in design, composition, performance, intended use, safety and effectiveness" to predicate products (Pulpdent Resin Bonding Agent, Bisco Fortify, UltraDent PermaSeal). Laboratory testing showed "equivalent in physical and mechanical properties to the predicate products."

Note: The acceptance criteria here are qualitative (substantial equivalence) rather than specific quantitative performance metrics (e.g., bond strength exceeding a certain MPa). The "reported performance" is a general statement of equivalence based on the comparison to predicate devices and limited laboratory testing.

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

No specific sample size for a "test set" is mentioned.
The data provenance mentioned is "laboratory testing" for physical and mechanical properties, but no details on the specific samples or their origin are provided. The general statement about predicate devices refers to "General usage of these materials over about 20 years" and "virtually billions of procedures in the United States," referring to the broader safety profile of similar materials, not a specific test set for this device.

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. This submission relies on demonstrating equivalence to existing devices and their established safety and effectiveness. There is no mention of a "test set" requiring expert ground truth establishment in the context of clinical images or similar diagnostic data. The "ground truth" implicitly relies on the long-standing use and FDA approval of the predicate devices.

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

Not applicable. No clinical test set requiring 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

No. This product is a dental bonding agent, not an AI-powered diagnostic tool. Therefore, an MRMC study is not relevant or mentioned.

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

No. This is a material device, not an algorithm. Standalone performance as typically understood for AI/software devices is not applicable.

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

The "ground truth" for the submission is the long-standing regulatory acceptance and clinical use of predicate devices which are described as being "substantially equivalent" in design, composition, performance, intended use, safety, and effectiveness. The safety and effectiveness are supported by an appeal to "General usage of these materials over about 20 years" and "virtually billions of procedures in the United States," indicating a history of safe and effective use for the material class. Additionally, "laboratory testing has shown that Pulpdent Glaze II is equivalent in physical and mechanical properties to the predicate products," which serves as supporting evidence for the "performance" aspect of the substantial equivalence claim.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a physical dental material, not a machine learning model.

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

Not applicable. No training set is involved.

Summary

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PULPDENT CORPORATION

MAY 1 6 2002

KO20514

EXHIBIT 2

SUMMARY OF SAFETY AND EFFECTIVENESS DATA

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

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

DEVICE: Trade Name: PULPDENT GLAZE II Classification Name: Agent, Tooth Bonding, Resin FDA Product Code: 76 KLE, 21 CFR Part 872.3200

PREDICATE DEVICE:

Pulpdent Resin Bonding Agent Bisco Fortify UltraDent PermaSeal

DESCRIPTION AND INTENDED USE:

COMPARISON WITH PREDICATE PRODUCTS:

PULPDENT GLAZE II substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above.

SAFETY AND EFFECTIVENESS:

PULPDENT GLAZE II is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above. The predicate products have been found substantially equivalent under the 510(k) premarket notification process as Class II Dental Devices under CFR 872.3200. Though there is no ISO or ANSI/ADA standard applicable to Pulpdent Glaze II, laboratory testing has shown that Pulpdent Glaze II is equivalent in physical and mechanical properties to the predicate products,

According to the NH Technology Assessment Conference on Effects and Side-Effects of Dental Restorative Materials: "General usage of these materials over about 20 years indicates a high benefit-torisk ratio...both composites and glass ionomers are relatively trouble-free. There is no evidence of shortterm or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 6 2002

Mr. Kenneth J. Berk Director Pulpdent Corporation 80 Oakland Street Watertown, Massachusetts 02472

Re: K020514

Trade/Device Name: Pulpdent Glaze II Regulation Number: 21 CFR 872.3200 Regulation Name: Agent, Tooth Bonding, Resin Regulatory Class: II Product Code: KLE Dated: February 12, 2002 Received: February 15, 2002

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.

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.

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

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Page 2 - Mr. Berk

and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alle libang (21 CFF an in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as between a 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 110(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 n you debire ope 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely,

Patricia Curente /for

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

Enclosure

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INDICATIONS FOR USE STATEMENT

K020514

510 (k) Number (if known)

PULPDENT GLAZE II Device Name

Indications for Use:

Pulpdent Glaze II is a light-cured, unfilled resin that contains no Bisphenol A and is r alpaon. One if to a light sealer and bonding agent. Pulpdent Glaze II bonds to composite and etched enamel, seals composite margins, penetrates and seals composite surface, reducing micro-leakage, wear and marginal breakdown.

Please do not write below this line. Continue on another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne
Division Sign-Off

fon of Dental, Infection Control, and General Hospital Devices

510(k) Number K020514

Prescription Use レ (Per 21 CFR 801.109) - or

Over-The-Counter Use

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.