(77 days)
Seal & Protect™ Protective Sealant is a protective sealant for exposed dentine. 'The indications for use are:
- Reduction of abrasion and erosion of exposed cervical dentine .
- Treatment of hypersensitive cervical areas .
Seal & Protect™ Protective Varnish is a nanofilled light-curing dental varnish designed to protect exposed dentine areas, both mechanically and by way of an antimicrobial agent.
This 510(k) summary describes a device (Seal & Protect™ Protective Sealant) that is considered substantially equivalent to a predicate device (Seal & Protect™ Protective Varnish K992822). The submission states that the new device is "identical to K992822, with the exception of the addition of a contraindication." Therefore, the focus is on demonstrating this equivalence rather than providing a separate study with acceptance criteria for the new device's performance.
Based on the provided document, there is no study conducted for Seal & Protect™ Protective Sealant to demonstrate its performance against specific acceptance criteria.
The entire premise of this 510(k) submission is that the new device is functionally the same as the predicate device, with only a minor change (an added contraindication). Therefore, the performance is assumed to be equivalent to the predicate device, for which performance would have been established previously.
Here's a breakdown based on your requested information, highlighting why much of it is not applicable or not provided in this specific 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
Explanation: This 510(k) relies on substantial equivalence to a predicate device (Seal & Protect™ Protective Varnish K992822) rather than presenting new performance data against acceptance criteria for the "new" device. The claim is that the device is "identical... with the exception of the addition of a contraindication," implying its performance is the same as the predicate.
Regarding a study proving the device meets acceptance criteria: There is no study described in this 510(k) pertaining to the performance of Seal & Protect™ Protective Sealant against specific acceptance criteria. The submission is a claim of substantial equivalence based on the device being nearly identical to a previously cleared product.
Therefore, the following points are not applicable or cannot be answered from the provided text:
2. Sample size used for the test set and the data provenance: Not applicable, as no new performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 sealant, 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 not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.