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510(k) Data Aggregation
K Number
K242537Device Name
BracePaste Fluoride Sealant
Manufacturer
American Orthodontics Corp.
Date Cleared
2024-08-27
(1 days)
Product Code
DYH
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
American Orthodontics Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BracePaste Fluoride Sealant is a light-cure primer / sealant intended to be used in the bonding procedure (direct or indirect) of orthodontic bondable devices by preparing the bonding surface during orthodontic treatment to the etched enamel.
BracePaste Fluoride Sealant is indicated for the orthodontic treatment of malocclusions and craniofacial abnormalities as diagnosed by a trained dental professional or orthodontist.
Device Description
American Orthodontics' BracePaste Fluoride Sealant is a light-curing primer that is intended for use in orthodontic treatment as diagnosed by a trained dental professional or orthodontist. The primer prepares the enamel during orthodontic treatment to increase adhesion to the bonding surface by wetting the bonding surface of the object to be bonded.
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