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Pit & Fissure Sealant with Fluoride is a light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth.

The Pit & Fissure Sealant with Fluoride is available in clear, opaque and linted shades, when differen! shades are indicated for use.

Pit & Fissure Sealant with Fluoride is a light-activated dental sealant for sealing pits and fissures in primary or permanent posterior teeth. The Pit & Fissure Sealant with Fluoride is available in clear, opaque and linted shades.

This is a 510(k) clearance letter from the FDA for a dental sealant. This document does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it states that the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text.

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This is a chemically activated sealant that is used to seal the pit ad fissures found in primary and secondary dentition in combination with the acid etching technique. This sealant assures complete cure in deep fissures.

Pit and Fissure Sealant

The provided text is a 510(k) clearance letter from the FDA for a dental pit and fissure sealant. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or any other details about a study. This document is solely an FDA clearance letter confirming substantial equivalence to a predicate device.

Ask a specific question about this device