(87 days)
PULPDENT Triple-Cure™ Reinforced Glass Ionomer Orthodontic Cement is a multi-purpose orthodontic cement that can be used as a bracket adhesive and as a band cement. It combines the advantages of glass ionomer cement with the added strength of dental resin technology. Triple-Cure™ is a fluoride releasing, light-cure, self-cure, glass ionomer dental adhesive in powder and liquid form. It is used with an enamel etching gel to adhere orthodontic brackets to tooth surfaces
PULPDENT Triple-Cure™ Reinforced Glass lonomer Orthodontic Cement is a multi-purpose orthodontic cement that can be used as a bracket adhesive and as a band cement. It combines the of thouonic cement that ban be dood as a bracked as a brache of early of the edire" ("" (" is a fluoride releasing, light-cure, glass ionomer dental adhesive in powder and liquid form. It is used with an enamel etching gel to adhere orthodontic brackets to tooth surfaces.
The provided Premarket Notification (510(k)) for the PULPDENT Triple-Cure™ Reinforced Glass Ionomer Orthodontic Cement does not contain a study that establishes specific acceptance criteria and then proves the device meets those criteria through empirical testing.
Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices, as well as referencing general information about the safety and effectiveness of similar materials.
Here's a breakdown based on the information provided and what is explicitly missing in relation to your request about acceptance criteria and a study proving their fulfillment:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: No specific numerical or qualitative acceptance criteria (e.g., minimum bond strength, maximum debonding rate, fluoride release levels, etc.) are stated in the document.
- Reported Device Performance: No specific performance data for the Pulpdent Triple-Cure™ device is reported. The document states it "combines the advantages of glass ionomer cement with the added strength of dental resin technology" but provides no quantitative evidence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No test set or associated study data proving performance are presented.
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. No ground truth establishment related to specific performance testing is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication process 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
- Not applicable. This type of study (MRMC, AI assistance) is completely irrelevant to a dental cement device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This question pertains to AI/algorithm performance and is not relevant to this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth for device performance is established or used in a study described here. The "ground truth" for the submission's argument is the established safety and effectiveness of the predicate devices and the general usage of similar materials over time.
8. The sample size for the training set
- Not applicable. This question relates to machine learning models and is not relevant to this dental cement.
9. How the ground truth for the training set was established
- Not applicable. This question relates to machine learning models and is not relevant to this dental cement.
Summary of the FDA's decision based on the provided text:
The FDA granted 510(k) clearance based on substantial equivalence to predicate devices (GC Fuji Ortho LC, GC Fuji Ortho Self-cure, Pulpdent Band-Rite). The argument for safety and effectiveness is largely based on:
- The device being "substantially equivalent in composition and intended use" to already approved predicate devices.
- Broad statements about the "high benefit-to-risk ratio" and "trouble-free" nature of similar materials (composites and glass ionomers) over "about 20 years," citing an NIH Technology Assessment Conference.
- The fact that predicate products have already received 510(k) premarket approval.
In essence, this submission does not contain empirical performance data generated from a specific study with defined acceptance criteria for the Pulpdent Triple-Cure™ device itself. It relies on the regulatory pathway of substantial equivalence, asserting that because it is similar enough to already-approved and widely-used devices, it is safe and effective without needing new, independent performance studies beyond what's stated.
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.