Embrace™ WetBond™ Clear Sealant is a hydrophilic, light-cured material recommended for use as a pit and fissure sealant. Embrace™ WetBond™ Clear Sealant may be used to seal small defects such as buccal pits, lingual grooves or facial surface defects. Embrace™ WetBond™ Clear Sealant may also be used as an orthodontic bracket coating. Embrace™ WetBond™ Clear Sealant hardens/cures such that the material is clear.

Device Description

Embrace™ WetBond™ Clear Sealant is a hydrophilic, light-cured material recommended for use as a pit and fissure sealant. Embrace™ WetBond™ Clear Sealant may be used small defects such as puch pins, lingual grooves or facial sufface defects. Embrace™ WetBond™ Clear Sealant may also be used as an orthodontic bracket coating. Embrace™ WetBond™ Clear Sealant hardens/cures such that the material is clear.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Embrace™ WetBond™ Clear Sealant. This notification asserts substantial equivalence to existing predicate devices based on design, composition, and intended use, rather than presenting a study to define and meet specific acceptance criteria in the way that would typically be done for a novel AI/software device.

Therefore, many of the requested categories for AI/software device studies are not applicable to this submission. The submission relies on existing knowledge about the safety and effectiveness of the chemical components and predicate devices, supported by laboratory testing on physical/mechanical properties and post-market surveillance of similar products.

Here's an attempt to address the requested information based on the provided text, indicating where information is not applicable (N/A) due to the nature of the device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance	Comments
Equivalence to Predicates	Embrace™ WetBond™ Clear Sealant is substantially equivalent in design, composition, performance, intended use, safety, and effectiveness to the predicate products.	This is the primary "acceptance criterion" for a 510(k) submission, demonstrating that the new device is as safe and effective as devices already on the market.
Chemical Composition	The chemicals in Embrace™ WetBond™ Clear Sealant are the same as those used in the Pulpdent predicate products and equivalent to those used in the other predicate products.	A key factor in establishing substantial equivalence.
Physical/Mechanical Properties	Laboratory testing has shown that Embrace™ WetBond™ Clear Sealant is equivalent in physical and mechanical properties to the predicate products.	Specific metrics for these properties are not detailed in the summary, but equivalence to predicates is asserted.
Clinical Performance (Indirect)	Four studies, carried out on similar products with the same Embrace™ WetBond™ resin base, demonstrate the effectiveness of Embrace™ WetBond™ materials. These include: - Penetration depth and marginal leakage - Microleakage of surface sealants - Toothpaste/toothbrush abrasion resistance - Clinical performance of Embrace™ WetBond™ Pit and Fissure Sealant.	While not direct studies on the Clear Sealant, these serve as evidence of the effectiveness of the underlying resin technology, supporting the claim of substantial equivalence.
Safety - Post-Market Surveillance	Four years of post-market surveillance of the two Pulpdent predicates has demonstrated only positive feedback, with no serious complaints, failures, or injuries.	This provides real-world safety data for similar materials.
Safety - General Usage	NIH Technology Assessment Conference 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 broad statement on the safety of dental restorative materials (composites and glass ionomers) provides context for the safety of this type of device.

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

Sample size for test set: Not explicitly stated for specific tests directly of the Embrace™ WetBond™ Clear Sealant within this summary. The "four studies" were conducted on "similar products with the same Embrace™ WetBond™ resin base." One clinical study is mentioned ("Clinical performance of Embrace™ WetBond™ Pit and Fissure Sealant. Dr. JP O'Donnell. 2005."), but the sample size and provenance details are not provided in this submission summary.
Data provenance:
- "Penetration depth and marginal leakage..." - Professor Michael DeGrange, Biomaterials Innovations Research Development Laboratory, Paris, France. (2001, 2002)
- "Microleakage of surface sealants in Class V restorations after thermal cycling." - Pulpdent Corporation.
- "In vitro study on toothpaste / toothbrush abrasion resistance of a new dental material: Seal-n-Shine." - Pulpdent Corporation.
- "Clinical performance of Embrace™ WetBond™ Pit and Fissure Sealant." - Dr. JP O'Donnell. (2005)
- The studies mentioned appear to be a mix of in-vitro (laboratory) and potentially in-vivo (clinical) based on their titles. The submission doesn't explicitly state if the clinical study was prospective or retrospective here.

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

N/A. For direct testing of the Embrace™ WetBond™ Clear Sealant, the submission relies on laboratory testing and reference to prior studies, not on expert consensus to establish ground truth in the context of diagnostic performance. For the referenced studies, the experts are listed as "Professor Michael DeGrange" and "Dr. JP O'Donnell," implying their scientific and clinical expertise, respectively, but no panel or number of experts for "ground truth" establishment is detailed.

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

N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials involving human interpretation of diagnostic results. This submission focuses on material properties and clinical performance of a sealant, not diagnostic interpretation.

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

N/A. This device is a pit and fissure sealant, not an AI or diagnostic imaging device. Therefore, MRMC studies and AI assistance are not relevant.

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

N/A. This device is a material, not an algorithm.

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

For the laboratory studies, the "ground truth" would be established by the physical and mechanical measurement standards and protocols relevant to dental materials (e.g., measuring penetration depth, leakage, abrasion resistance).
For the clinical study, "outcomes data" related to sealant performance (e.g., retention, caries prevention) would be the ground truth.
For substantial equivalence, the "ground truth" is defined by the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

N/A. This is a material device, not a machine learning model. There is no "training set."

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

N/A. As there is no training set for a machine learning model, this question is not applicable.

Summary

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510 k Premarket Notification K052281 2008 FEB 8 EMBRACE™ WETBOND™ CLEAR SEALANT

EXHIBIT 2 (REVISED)

SUMMARY OF SAFETY AND EFFECTIVENESS DATA

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

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

DEVICE NAME: Embrace™ WetBond™ Clear Sealant

PREDICATE DEVICES:

Pulpdent Embrace™ Pit and Fissure Sealant	Dentsply Delton Clear
Pulpdent Embrace™ Seal-n-Shine	Bisco BisCover
	Cosmedent CosmeSeal

DESCRIPTION AND INTENDED USE:

COMPARISON WITH PREDICATE PRODUCTS:

Embrace™ WetBond™ Clear Sealant is substantially equivalent in design, composition and intended use to the products listed above. Please see Exhibit 4 for the entire comparison.

SAFETY AND EFFECTIVENESS:

Pulpdent Embrace™ WetBond™ Clear Sealant 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. Dences under 872.3310 or 872.3765. The chemical in Embrace™ WetBond™ Clear Sealant are the same as those used in the Pulpdent predicate products and equivalent to those used in the other products.

Four studies, carried out on similar products with the same Embrace™ WetBond™ resin base, demonstrate the effectiveness of Embrace™ WetBond™ materials.

Penetration depth and marginal leakage of Embrace™ WetBond™ Pit and Fissure Sealant and Small Lesion Restorative Material. Professor Michael DeGrange, Biomaterials Innovations Research Development Laboratory, Paris, France. 2001, 2002.
- Microleakage of surface sealants in Class V restorations after thermal cycling. Pulpdent Corporation.
- In vitro study on toothpaste / toothbrush abrasion resistance of a new dental material: Seal-n-Shine. Pulpdent Corporation.
· Clinical performance of Embrace™ WetBond™ Pit and Fissure Sealant. Dr. JP O'Donnell. 2005.

There is no ISO or ANSIIADA standard applicable to Embrace™ Clear Sealant. Laboratory testing has shown that Embrace™ WetBond™ Clear Sealant Is equivalent in physical and mechanical properties to the predicate products. Four years of post-market surveillance of the two Pulpdent predicate has demonstrated only positive feedback from our customers. There have been no serious complaints or failures and no injuries to patients or dental professionals. According to the NIH Technology Assessment Conference and Effects and Side-Effects of Dental Restorative Materials: "General usage of these materials over about 20 years indicates a high benefit-to-risk ratio...Both composites and glass ionomers are relatively trouble-fraour is no evidence of short-term or long-term risk...There is no suspicion of any problems after virtually hillions 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 and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 FEB 8

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

Re: K052281

Trade/Device Name: Embrace™ WetBond™ Clear Sealant Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC, EBD Dated: January 31, 2006 Received: February 6, 2006

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 (240) 276-0115. 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/cdrh/industry/support/index.html.

Sincerely yours,

Serita Y. Michael Davis

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

510(k) Number: K052281

Device Name: Embrace™ WetBond™ Clear Sealant

Indications for Use:

Prescription Use
(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)

Sven Russo

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ാ വില്ലിപ്പോൾന്മൃ. General Hospit Joh Control. Dental Devices

K(5522)X

Regulation Number and Section

§ 872.3765 Pit and fissure sealant and conditioner.

(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.