(82 days)
Intended for use as a varnish on sensitive teeth, over exposed dentin under temporary restorative and cements where post-operative sensitive and compressive and coments and cements when used in conjunction with dental restoratives and cements.
Product is also intended for use to seal dentinal tubules in cavity preparations or on sensitive root surfaces.
5% sodium fluoride in a solvent base
The provided text describes a 510(k) submission for a dental varnish (Flor-Opal Varnish) and focuses on establishing its substantial equivalence to predicate devices, rather than performing a study with acceptance criteria and device performance metrics.
Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, or ground truth establishment for the training set, as these details are not present in the document.
The document states:
- Intended Use: The Flor-Opal Varnish has the same intended use as predicate devices: as a varnish on sensitive teeth, over exposed dentin, under temporary restoratives and cements, and on exposed dentin on roots.
- Technological Characteristics: The technological characteristics are "virtually the same" as predicate devices, with "no significant variation."
- Materials: The materials are considered "substantially equivalent" as they are used for the same purpose and have "relatively the same properties, etc."
- Similarities to Predicate Devices:
- 5% sodium fluoride in a solvent base
- Dentinal tubule obturator for the reduction in dental hypersensitivity
- Dentist administered
- Differences from Predicate Devices: The document mentions a heading for "Differences" but the content under it is nonsensical ("1. The Partify of Children Children Children..."). It then states, "No significant differences noted with any of the predicate devices and the Flor-Opal Varnish identified, of the No significan unter thes noted with any of the picture and incredients. All have the same concentration of the active ingredient." This implies that no meaningful or relevant differences were found that would affect substantial equivalence.
In summary, the document addresses substantial equivalence by comparing the new device to existing predicate devices based on intended use, technological characteristics, and materials, rather than presenting a performance study against predefined acceptance criteria.
§ 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.