Pulpdent VLC Resin Coment is a fluoride releasing, visible light-cure dental resin rement that contains no Bisphenol A. It is used to permanently cement ceramic coment that contains no crowns, inlays, onlays, bridges, bridges, veneers, and periodontal splints to tooth structure.

Device Description

PULPDENT VLC Resin Cement is a fluoride-releasing, visible light cure dental resin cement that contains no Bisphenol A.

AI/ML Overview

The provided document is a 510(k) premarket notification for a dental cement, PULPDENT VLC RESIN CEMENT, from 2004. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics in the way a medical device approval for a novel AI algorithm might.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance, is not present in this document. This is typical for a 510(k) for a dental material like cement, where substantial equivalence is often based on material properties, intended use, and a history of safe use of similar materials.

Here's what can be extracted and what cannot:

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

Acceptance Criteria (Implied by 510(k) process)	Reported Device Performance (as stated in the document)
Substantial equivalence in design, composition, performance, intended use, safety, and effectiveness to predicate devices.	"PULPDENT VLC Resin Cement is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above."
Safe operation.	"General usage of these materials over about 20 years indicates a high benefit-to-risk ratio...both composites and glass ionomers are relatively trouble-free. There is no evidence of short-term or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States." (Referring to the class of materials, not specifically the device's performance, but implying safety based on historical use).
Effectiveness for stated indications.	Intended Use: "permanently cement ceramic restorations, such as Cerec, porcelain crowns, inlays, onlays, bridges, veneers and periodontal splints to tooth structure."
No Bisphenol A.	"contains no Bisphenol A."
Fluoride-releasing.	"is a fluoride-releasing"
Visible light cure.	"visible light-cure dental resin cement"

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

Not Applicable / Not Provided. The document does not describe a "test set" in the context of clinical performance evaluation with a specified sample size. Substantial equivalence for this type of device is typically based on material property testing, biocompatibility, and comparison to existing products, rather than a clinical trial with a "test set" of patients.

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

Not Applicable / Not Provided. This information is for clinical and AI device evaluations, not relevant for this 510(k) submission of a dental cement.

4. Adjudication method for the test set

Not Applicable / Not Provided. No "adjudication method" for a test set 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 / Not Provided. This document is for a dental cement, not an AI-assisted diagnostic device, so an MRMC study is not relevant.

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

Not Applicable / Not Provided. This document is for a dental cement, not an algorithm, so standalone performance is not relevant.

7. The type of ground truth used

Not Applicable / Not Provided. The concept of "ground truth" as it applies to clinical data for diagnostic performance is not relevant here. The "truth" for this device lies in its material properties, biocompatibility, and successful adhesion/retention as a dental cement, which are assessed through laboratory testing and predicate comparison, not clinical outcome "ground truth" derived from patient data in the context of diagnosis.

8. The sample size for the training set

Not Applicable / Not Provided. This device is a material, not an AI algorithm, so there is no training set.

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

Not Applicable / Not Provided. As there is no training set, this question is not applicable.

Summary

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Ko40236

APR 2 0 2004

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

DEVICE: Trade Name: PULPDENT VLC RESIN CEMENT Classification Name: Dental Cement FDA Product Code: 76 EMA, 21 CFR Part 872.3275

PREDICATE DEVICE:

Pulpdent Post Cement Pulpdent ResiLute Kuraray / J. Morita Panavia F ESPE Compolute Aplicap lvoclar / Vivadent Variolink II

DESCRIPTION AND INTENDED USE:

PULPDENT VLC Resin Cement is a fluoride-releasing, visible light cure dental resin cement that contains no Bisphenol A. It is used to permanently cement ceramic restorations, such as Cerec, porcelain crowns, inlays, onlays, bridges, veneers and periodontal splints to tooth structure.

COMPARISON WITH PREDICATE PRODUCTS:

PULPDENT VLC Resin Cement is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above.

SAFETY AND EFFECTIVENESS:

PULPDENT VLC Resin Cement 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 872.3275.

According to the NIH 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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 0 2004

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

Re: K040236

Trade/Device Name: Pulpdent VLC Resin Cement Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: January 28, 2004 Received: February 2, 2004

Dear Mr. Berk:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have rother of a now and have determined the device is substantially equivalent (for the icitications 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to active 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 upprovisions of the Act. The general controls provisions of the Act include controls providents of the sixtation, 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 If your device to such additional controls. Existing major regulations affecting (1 Mrs), it may of subject to back of federal Regulations, Title 21, Parts 800 to 898. In your device ear be fourther announcements concerning your device in the Federal Register.

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Page 2 - Mr Berk

Please be advised that FDA's issuance of a substantial equivalence determination does not Please oe advisou mat 1 DTC Isbance or abat your device complies with other requirements mean that FDA has made a detes and regulations administered by other Federal agencies. of the Act of ally I ederal states and regirements, including, but not limited to: registration 1 ou must comply with an alle Hotel Stag (21 CFR Part 801); good manufacturing practice alla listing (21 CF R Part 807), abality systems (QS) regulation (21 CFR Part 820); and if requirenchts as set form in the quarty ajon 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) This letter will anow yourse overnment of substantial equivalence of your device to a premaired 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), If you desire speomle at 100 to: Join we at (301) 594-4613. 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 may obtain other generational 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 yours,

Ken Mulvey

for 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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INDICATIONS FOR USE

K040236 AND 200

510 (k) Number (if known)

PULPDENT VLC RESIN CEMENT Device Name

Indications for Use:

Prescription Use __ (Part 21 CFR 801 Subpart D) ா

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) (Division Sign-C (Division Sign-Off)
Division of Anesthesiology - . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Division of Anesthoolorsis Devices 444 510(k) Number: Page 1 of 1

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.