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K Number
K011491
Device Name
HELIOSEAL CLEAR CHROMA
Manufacturer
IVOCLAR NORTH AMERICA, INC.
Date Cleared
2001-08-16

(93 days)

Product Code
EBC
Regulation Number
872.3765
Type
Traditional
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
K091632
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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.