(87 days)
Pulpdent No-Mix Orthodontic Bracket Adhesive is a self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (38% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces.
PULPDENT No-Mix Orthodontic Bracket Adhesive is a fluoride-releasing, self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (38% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces.
The provided text is a 510(k) Premarket Notification for a dental adhesive. It focuses on establishing substantial equivalence to existing predicate devices rather than directly presenting acceptance criteria and detailed study performance data for a new, innovative device that would typically involve such a study.
Therefore, many of the requested categories for information about acceptance criteria, study details, and ground truth establishment are not directly available or applicable in this document. The submission's core argument is that the "Pulpdent No-Mix Orthodontic Bracket Adhesive" is "substantially equivalent" to already approved devices, implying it meets the same safety and effectiveness standards without requiring new, specific performance studies outlined here.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Safety and Effectiveness | The device must demonstrate safety and effectiveness for its intended use, especially given the "high benefit-to-risk ratio" of similar materials over 20 years, with "no evidence of short-term or long-term risk" and "no suspicion of any problems after virtually billions of procedures." It must also align with the safety and effectiveness profile of predicate devices. | The document states that "PULPDENT No Mix Orthodontic Adhesive is substantially equivalent in composition and intended use to the predicate product listed above." This implies that it meets similar safety and effectiveness standards, as the FDA later concludes that the device is "substantially equivalent" to legally marketed predicate devices, hence permitting its market entry. |
| Substantial Equivalence | The device must be "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" (as per the FDA's letter). This implies that its technological characteristics and performance are comparable to the predicate devices. | The FDA concluded that the device is "substantially equivalent" to the predicate devices. The submission itself states, "PULPDENT No Mix Orthodontic Adhesive is substantially equivalent in composition and intended use to the predicate product listed above." (Predicate devices listed are GAC OrthoLoc, GAC One-Step, Reliance Rely-a-Bond No Mix Orthodontic Adhesive, and Reliance Rely-a-Bond w/Fluoride No Mix Adhesive). This equivalence is the primary "performance" demonstrated for this 510(k) submission. |
| Composition and Intended Use | The device's composition and intended use should be comparable to predicate devices. | "PULPDENT No Mix Orthodontic Adhesive is substantially equivalent in composition and intended use to the predicate product listed above." The intended use is clearly defined as "a self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel (38% phosphoric acid gel) to adhere orthodontic brackets to tooth surfaces." Composition is generally described as a "fluoride-releasing, self-cure orthodontic bracket adhesive used with a liquid primer and an enamel etching gel." Specific compositional details for comparison are not provided in this excerpt but would have been in Exhibit 4 (not included). |
Since this is a 510(k) submission based on "substantial equivalence" to predicate devices, a detailed standalone study with specific acceptance criteria and performance metrics for this new device is not typically required in the same way as for novel devices. Instead, the argument relies heavily on the established safety and effectiveness of the predicate devices.
Given the nature of the provided document, the following points cannot be extracted directly from the text:
2. Sample size used for the test set and the data provenance: Not mentioned. The reliance is on the general history and performance of similar materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/mentioned. Ground truth is not established in the context of new data generation for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/mentioned.
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 is a dental adhesive, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a dental adhesive.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated for this device. The submission relies on the established safety and long-term history of similar dental materials, citing "general usage...over about 20 years" and "virtually billions of procedures in the United States" for composites and glass ionomers. implicitly, the "ground truth" for these materials is their proven track record of safety and efficacy.
8. The sample size for the training set: Not applicable/mentioned. This document does not describe a machine learning model.
9. How the ground truth for the training set was established: Not applicable/mentioned. This document does not describe a machine learning model.
§ 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.