(48 days)
Vanish Varnish is for use on sensitive teeth, over exposed dentin and root surface sensitivity and under temporary restoratives and cements where post-operative sensitivity is of concern.
Vanish™ Varnish, 5% Sodium Fluoride Varnish is classified as Cavity Varnish (21 C.F.R§872.3260) because it is a device that provides relief from tooth surface hypersensitivity when applied to enamel and dentin surfaces by forming a film that facilitates occlusion of compromised surfaces including open dentinal tubules.
Vanish Varnish is a topically applied. flavored cavity varnish containing sodium fluoride in a rosin based preparation. The varnish is an insoluble viscous liguid that forms a film on tooth surfaces. This dispensing system provides simultaneous dispensing of each component for a consistent mix.
The chemical composition is identical to predicate fluoride containing rosin based cavity varnish devices that have been in use for decades. The data provided in this 510(k) submission shows that the composition is safe based on the biocompatibility assessment conducted based on ISO10993 and ISO 7405.
This product is equivalent to current varnishes in properties. intended use and composition. Results provided in the submission confirm the equivalent to the predicate devices with common indications.
The provided text is insufficient to answer the request. The document describes a 510(k) summary for a dental product (Vanish Varnish), outlining its classification, predicate devices, description, and indications for use. It primarily focuses on demonstrating substantial equivalence to existing devices.
However, the text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The document confirms that the chemical composition and properties are "equivalent to current varnishes" and "confirm the equivalent to the predicate devices with common indications," but it does not present the specific data or studies that prove this equivalence in the format requested.
Therefore, I cannot extract the requested information from the provided text.
§ 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.