PRG BARRIER COAT by SHOFU DENTAL CORPORATION | FDA 510(k) Summary

FDA 510(k) Search

K Number

Device Name

PRG BARRIER COAT

Manufacturer

SHOFU DENTAL CORPORATION

Date Cleared

2013-04-26

(217 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

PRG BARRIER COAT, is a light-cured two-component mixing type, tooth surface coating material as well as desensitizer to relieve dentin hypersensitivity.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA 510(k) notification does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. This document is a clearance letter and indications for use, not a detailed study report. Therefore, I cannot generate the requested table and information.

Summary

Regulation Number and Section

§ 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.