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K Number
K990650
Device Name
CONSEAL F
Manufacturer
SOUTHERN DENTAL INDUSTRIES, INC.
Date Cleared
1999-05-14

(74 days)

Product Code
EBC
Regulation Number
872.3765
Type
Traditional
Panel
DE
Reference & Predicate Devices
K990652
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Pit and fissure sealant and conditioner for use in sealing pit and fissure depression of teeth.

Device Description

Not Found

AI/ML Overview

The provided text is a letter from the FDA regarding the clearance of a dental device named "Conseal F." It is a regulatory document and does not contain information about the acceptance criteria, study details, or performance metrics of the device.

Therefore, I cannot provide the requested information. The document solely confirms the clearance of Conseal F as substantially equivalent to previously marketed devices based on its indications for use as a "Pit and fissure sealant and conditioner for use in sealing pit and fissure depression of teeth."

§ 872.3765 Pit and fissure sealant and conditioner.

(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.