ALPHA-PRO WHITE VARNISH

• K Number: K124025
• Device Name: ALPHA-PRO WHITE VARNISH
• Manufacturer: DENTAL TECHNOLOGIES, INC.
• Date Cleared: 2013-09-18 ( 264 days)
• Product Code: LBH
• Regulation Number: 872.3260
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

• Treatment of hypersensitive teeth.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding "Alpha-Pro White Varnish." It is not a study or regulatory document that contains the detailed information requested.

Therefore, I cannot provide the acceptance criteria and study details you've asked for based on the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not include performance data, detailed study designs, or acceptance criteria.

To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a detailed submission document that describes the studies conducted for this device.

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.