(105 days)
SmartCoat 2.5% NaF Varnish is intended for use on sensitive teeth, over exposed dentin . and root surface sensitivity, and under temporary restorations or cements where post operative sensitivity is of concern.
. Rapid Desensitizer
. Provides rapid relief from sensitive teeth due hypersensitivity
SmartCoat 2.5% NaF Varnish is classified as a Cavity Varnish (21 CFR 872.3260) because it is a device that provides relief from tooth surface hypersensitivity when applied to dentin surfaces by forming a film that facilitates occlusion of compromised surfaces including open dentinal tubules.
SmartCoat is a topically applied, flavored cavity varnish containing sodium fluoride in a shellac resin based preparation. The varnish is an insoluble viscous liquid that dries once applied to the teeth to form a surface film. The packaging provides an accurate dosing and uniform dispensing mechanism for consistent product mixing and delivery.
The provided document describes the acceptance criteria and a study to demonstrate the performance of the SmartCoat™ 2.5% NaF Varnish.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Dentin Tubule Occlusion: The varnish should effectively occlude compromised dentin surfaces, including open dentinal tubules, to provide relief from tooth surface hypersensitivity. | Image Analysis Rating: For all measured time points (immediately after application, 3 days, and 6 days), occlusion ratings for SmartCoat Varnish were 6 on a scale of 1-6 (where 6 = complete occlusion). |
| Qualitative Observation: All dentinal tubules initially covered remained covered throughout the entire 6-day treatment period. Nearly no visible dentinal tubules were observed in the coated area. The only visible tubules were still covered by a transparent layer of SmartCoat near the border. | |
| Longevity/Durability of Occlusion: The occlusion should be maintained over a period of time despite exposure to an oral environment. | Occlusion was maintained for 6 days under vigorous stirring in de-ionized water, with the varnish layer remaining effective. The study demonstrated consistent occlusion over this period. |
| Safety and Biocompatibility: The chemical components should be safe for intended use and biocompatible. | The chemical components are similar to predicate devices, many are listed as GRAS (Generally Recognized As Safe) ingredients, or both. Shellac and ammonium phosphate have extensive safe use in food and dental applications. Biocompatibility assessment and risk assessment were conducted according to ISO 10993 and ISO 14971, supporting safety. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: "Human dentin slabs" were prepared and used. The exact number of slabs (sample size) is not specified in the document.
- Data Provenance: The study was a bench performance test conducted in a lab setting, not involving human subjects. The provenance of the human dentin slabs (e.g., country of origin) is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- The document states that the testing involved "subjective light microscopy analysis." It does not specify the number of experts or their qualifications for establishing the ground truth (i.e., rating the occlusion).
4. Adjudication Method for the Test Set:
- The document implies a subjective analysis but does not specify any formal adjudication method (like 2+1, 3+1, or none) for the assessment of dentin tubule occlusion. Ratings were assigned, but the process of how these ratings were finalized is not detailed.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The described study is a bench performance test focused on the physical occlusion property of the varnish, not on human reader performance, with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a dental varnish, not an algorithm or AI system. The performance study evaluates the physical properties of the varnish itself.
7. The Type of Ground Truth Used:
- The ground truth for this bench test was established by subjective light microscopy analysis at 500x magnification to observe dentin tubule occlusion. This involved visual assessment and ranking on a defined scale.
8. The Sample Size for the Training Set:
- Not applicable. This device is a dental varnish, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for a machine learning model, this question does not apply.
§ 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.