(79 days)
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.
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.
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.
§ 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.