Embrace ™ WetBond ™ Restoration & PFM Repair Kit is a convenience kit used by the dentists to repair restorations. The components were designed for bonding to all restorative, metal and ceramic restorations. The components were designed for bonding to all restorative, metal and ceramic surfaces, including precious and non-precious metals, porcelain and enamel. The Kit provides materials to prepare, prime, protect, opaque, and restore materials.

Device Description

Embrace™ WetBond™ Restoration & PFM Repair Kit is a convenience kit used by the dentist to repair restorations. The components were designed for bonding to all restorative, metal and ceramic restorations. The components include for preparing, priming, opaquing and protecting surfaces, and for sealing, finishing and polishing the final repair or restoration.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Embrace™ WetBond™ Restoration & PFM Repair Kit. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study with defined metrics.

Therefore, many of the requested sections (e.g., acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission.

The document primarily states that the device is "substantially equivalent" to legally marketed predicate devices and that its chemical ingredients are "used in the established dental materials." It mentions "laboratory testing [of] mechanical properties to the predicate products" but does not provide details about this testing, including specific acceptance criteria or results.

Here's a breakdown of what can be extracted or inferred based on the provided text:

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

Not applicable / Cannot be extracted. The document states: "Though there is no ISO or ANS/ADA standard applicable to Embrace™ WetBond™ Restoration & PFM Repair Kit, laboratory testing [of] mechanical properties to the predicate products." This indicates that direct performance against established standards with specific acceptance criteria is not presented. Instead, a comparison of mechanical properties to predicate devices was performed, but the criteria and results are not detailed.

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

Cannot be extracted. The document mentions "laboratory testing mechanical properties," but does not provide any details about the sample size, test set, or data provenance.

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 / Cannot be extracted. The submission is for a dental restoration kit, not an AI/diagnostic device that typically requires expert-established ground truth for performance evaluation.

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

Not applicable / Cannot be extracted. This type of adjudication is relevant for diagnostic studies, not for the evaluation of a dental material kit.

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 device is a dental material kit, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a dental material kit, not an algorithm.

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

Not applicable / Cannot be extracted. The ground truth in the context of a dental restoration kit would typically relate to mechanical properties, biocompatibility, and clinical outcomes. The document vaguely refers to "laboratory testing mechanical properties," but doesn't specify the "ground truth" or reference methods used for these evaluations. The primary "truth" here is its substantial equivalence to previously cleared devices.

8. The sample size for the training set

Not applicable. This device is a dental material kit, not a machine learning model that requires a training set.

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

Not applicable. This device is a dental material kit, not a machine learning model that requires a training set.

Summary of Safety and Effectiveness Data from K032953:

The core of the safety and effectiveness data for the Embrace™ WetBond™ Restoration & PFM Repair Kit, as presented in this 510(k) submission, relies on:

Substantial Equivalence: The primary argument is that the device is "substantially equivalent in design, composition, performance, intended use, safety and effectiveness" to three legally marketed predicate devices:
- Kuraray Clearfil Porcelain Repair Kit
- Ultradent Porcelain Repair Kit
- Ivoclar Vivadent Ceramic Repair Kit
  These predicates were previously cleared under the 510(k) process as Class II Dental Devices (CFR 872.3200).
Component Material Equivalence: The individual components of the Embrace™ WetBond™ Restoration & PFM Repair Kit were also found to be substantially equivalent to existing materials in the market.
Chemical Ingredients: The chemical ingredients used "are used in the established dental materials."
Laboratory Testing (Mechanical Properties): The document states that "laboratory testing [of] mechanical properties to the predicate products" was conducted. However, no specific details about the tests, methods, results, or acceptance criteria are provided in this summary.
General Clinical Experience with Dental Adhesives: The submission cites the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Adhesives, which states, "General usage of these materials over about 20 years indicates a high benefit-to-risk ratio. 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." This statement is used to support the general safety profile of dental adhesive materials.

In essence, the "study" demonstrating the device meets "acceptance criteria" is an argument for substantial equivalence to already cleared devices, supported by the common use of its chemical constituents and a general reference to comparable mechanical property testing. Specific quantitative performance data or traditional study designs with explicit acceptance criteria are not detailed in this provided text.

Summary

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KO 32953

PL LPDENT CORPORATION

510 k Premarket Notification Embrace™ WetBond™ Restoration & PFM Repair Kit

EXHIBIT 2

SUMMARY OF SAFETY AND EFFECTIVENESS DATA

Kenneth J. Berk 8 ) Oakland Street FO Box 780 V/atertown, MA 02472 USA

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

Embrace™ WetBond™ Restoration & PFM Repair Kit DEVICE: NAME:

I'REDICATE DEVICES:

Kuraray Clearfil Porcelain Repair Kit Ultradent Porcelain Repair Kit Ivoclar Vivadent Ceramic Repair Kit Components of the Embrace™ WetBond™ Restoration & PFM Kit Pulodent Embrace First Coat Pulodent Embrace Seal-n-Shine Pulpdent Embrace Opaquer Pulpdent Kool-Dam Pulpdent Porcelain Etch Gel

DESCRIPTION AND INTENDED USE:

Embrace™ WetBond™ Restoration & PFM Repair Kit is a convenience kit used by the dentist to repair restorations. The components were designed for bonding to all restorative, metal and ceramic restorations: The 'oumpensite' include tor preparing, priming, opaquing and protecting surfaces, and for sealing, finishing and polishing the final repair or restoration.

COMPARISON WITH PREDICATE PRODUCTS:

Embrace™ WetBond™ Restoration & PFM Repair Kit is substantially equivalent in design, composition
and intended use to the kits listed above. The component material Restoration & PFM Repair Kit have been found to be substantially equivalent under the 510(k) premarket notification process. Please see Exhibit 4 for the entire comparison.

SAFETY AND EFFECTIVENESS:

Embrace™ WetBond™ Restoration & PFM Repair Kit is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate 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.

The chemical ingredients used in Embrace™ WetBond™ Restoration & PFM Repair Kit are used in the r Fre cremiou in the established dental materials. Though there is no ISO or ANS/ADA
standard aplicable to Embrace " Welfond" (Restrailor & PFM Repair Kit, laboratory testin mechanical properties to the predicate products.

According to the NIH Technology Assessment Conference on Effects and Side-Effects of Dental Aoording to the high - "General usage of these materials over about 20 years indicates a high benefitto-risk ratio. 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."

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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 features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 2003

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

Re: K032953

Trade/Device Name: Embrace™ WetBond ™ Restoration & PFM Repair Kit Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 10, 2003 Received: September 22, 2003

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.

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance 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 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/cdrl/dsma/dsmamain.html

Sincerely yours,

Carls

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 STATEMENT

K032953

510 (k) Number (if known)

Device Name

Embrace ™ WetBond ™ Restoration & PFM Repair Kit

Indications for Use:

Indications for USe.
Embrace ™ WetBond ™ Restoration & PFM Repair Kit is a convenience kit used by
the all WetBond The liness The components were, designed for bonding Embrace ™ WetBond "" Restoration & PFM Repair Tor is a osh only of on all
dentists to repair restorations. The components were designed for all
e repair dentists to repair restorations. The components and non-precious and non-precious metals,
restorative, metal and ceramic surfaces, including precious and non-precious metals, restorative, metal and ceramic surfaces, including precious and non-protect, opaque,
prime, provides materials and restorative materials, porcelain and enamel: The Rit provides and restorative materials.

Susan Runn

(Division Sign-Division of Anesthesiology, General Hospital, Infection Control, Dental De

510(k) Number: K083215

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

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.