(90 days)
Pulpdent Glaze II is a light-cured, unfilled resin that contains no Bisphenol A and is used as a penetrating composite sealer and bonding agent. Pulpdent Glaze II bonds to composite and etched enamel, seals composite margins, penetrates and seals composite surface, reducing micro-leakage, wear and marginal breakdown.
Pulpdent Glaze II is a light-cured, unfilled resin that contains no Bisphenol A and is used as a penetrating composite sealer and bonding agent. Pulpdent Glaze II bonds to composite and etched enamel, seals composite margins, penetrates and seals composite surface, reducing micro-leakage, wear and marginal breakdown.
The provided text describes a 510(k) premarket notification for a dental device, PULPDENT GLAZE II. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials with detailed acceptance criteria and performance studies as might be seen for novel, higher-risk devices.
Here's an analysis of the provided text based on your request, highlighting what is (and isn't) present:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence in design, composition, performance, intended use, safety, and effectiveness to predicate devices. | Stated to be "substantially equivalent in design, composition, performance, intended use, safety and effectiveness" to predicate products (Pulpdent Resin Bonding Agent, Bisco Fortify, UltraDent PermaSeal). Laboratory testing showed "equivalent in physical and mechanical properties to the predicate products." |
- Note: The acceptance criteria here are qualitative (substantial equivalence) rather than specific quantitative performance metrics (e.g., bond strength exceeding a certain MPa). The "reported performance" is a general statement of equivalence based on the comparison to predicate devices and limited laboratory testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No specific sample size for a "test set" is mentioned.
- The data provenance mentioned is "laboratory testing" for physical and mechanical properties, but no details on the specific samples or their origin are provided. The general statement about predicate devices refers to "General usage of these materials over about 20 years" and "virtually billions of procedures in the United States," referring to the broader safety profile of similar materials, not a specific test set for this device.
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. This submission relies on demonstrating equivalence to existing devices and their established safety and effectiveness. There is no mention of a "test set" requiring expert ground truth establishment in the context of clinical images or similar diagnostic data. The "ground truth" implicitly relies on the long-standing use and FDA approval of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication 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
- No. This product is a dental bonding agent, not an AI-powered diagnostic tool. Therefore, an MRMC study is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a material device, not an algorithm. Standalone performance as typically understood for AI/software devices is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the submission is the long-standing regulatory acceptance and clinical use of predicate devices which are described as being "substantially equivalent" in design, composition, performance, intended use, safety, and effectiveness. The safety and effectiveness are supported by an appeal to "General usage of these materials over about 20 years" and "virtually billions of procedures in the United States," indicating a history of safe and effective use for the material class. Additionally, "laboratory testing has shown that Pulpdent Glaze II is equivalent in physical and mechanical properties to the predicate products," which serves as supporting evidence for the "performance" aspect of the substantial equivalence claim.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is a physical dental material, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. No training set is involved.
§ 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.