(68 days)
Pulpdent Glaze is a light-cured resin that contains no Bisphenol A and bonds tightly to enamel and composite restorations. Pulpdent Glaze can be used to seal composite surfaces, margins of restorations, cracks in teeth and restorations and to reduce micro-leakage. Two formulas can be used for dentin bonding.
Pulpdent Glaze is a light-cured resin that contains no Bisphenol A and bonds tightly to enamel and composite restorations. Pulpdent Glaze is offered in different formulations to meet the dental professional: filled, unfilled, very low filler level, no fluoride-releasing. Pulpdent Glaze can be used to seal composite surfaces, margins of restorations, cracks in teeth and restorations and to reduce micro-leakage. Two formulas can be used for dentin bonding.
The provided text is a 510(k) Premarket Notification for a dental device called "Pulpdent Glaze." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with acceptance criteria in the way a novel high-risk device might.
Therefore, many of the requested categories regarding acceptance criteria, specific study designs (like MRMC or standalone algorithm studies), sample sizes for test/training sets, and expert-established ground truth are not applicable to this document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (Pulpdent DenTASTIC UNO, Pulpdent Flows-Rite, UltraDent PermaSeal, UltraDent PermaQuick, Bisco Fortify, Kuraray Clear-Fil SE Bond, Kerr Opti Bond Solo Plus) in design, composition, performance, intended use, safety, and effectiveness. | "PULPDENT GLAZE is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above." |
| Equivalence in Physical and Mechanical Properties to predicate devices. | "laboratory testing has shown that Pulpdent Glaze is equivalent in physical and mechanical properties to the predicate products." |
| No BISPHENOL A content. | "contains no Bisphenol A" |
| Bonds tightly to enamel and composite restorations. | "bonds tightly to enamel and composite restorations" |
| Usable for sealing composite surfaces, margins of restorations, cracks in teeth and restorations, and reducing micro-leakage. | "Pulpdent Glaze can be used to seal composite surfaces, margins of restorations, cracks in teeth and restorations and to reduce micro-leakage." |
| Two formulas usable for dentin bonding. | "Two formulas can be used for dentin bonding." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document refers to "laboratory testing," but details on sample size for these tests are not provided.
- Data Provenance: Not explicitly stated beyond "laboratory testing." It's implied to be internal testing by Pulpdent Corporation. Retrospective or prospective is not specified, but typically lab testing for predicate equivalence would be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. The ground truth for this type of submission is primarily based on equivalence to predicate devices and established chemical/physical properties rather than a clinical expert consensus on complex outcomes. The "ground truth" for the device's properties would be determined by standard laboratory testing methodologies.
4. Adjudication Method for the Test Set:
- Not Applicable. As described above, this is not a study requiring expert adjudication of results.
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 is a dental material, not an AI or diagnostic imaging device. Therefore, no MRMC study was conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical dental material, not a software algorithm.
7. The Type of Ground Truth Used:
- The ground truth for demonstrating "safety and effectiveness" and "substantial equivalence" is based on:
- Chemical Composition: Comparison of ingredients to predicate devices.
- Physical and Mechanical Properties: Laboratory test results (e.g., bond strength, filler content, etc.) demonstrating equivalence to predicate devices.
- Intended Use: Alignment with the intended uses of predicate devices.
- Prior Regulatory Findings: The predicate devices themselves having been found substantially equivalent under 510(k) or regulated as Class II devices.
- General Clinical Experience/Scientific Consensus: Reference to the NIH Technology Assessment Conference on Dental Restorative Materials, which broadly states a high benefit-to-risk ratio for such materials over 20 years.
8. The Sample Size for the Training Set:
- Not Applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. (See point 8)
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.