Search Results
Found 1 results
510(k) Data Aggregation
K Number
K992838Device Name
ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE
Manufacturer
Date Cleared
1999-11-15
(84 days)
Product Code
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
BIOMAT SCIENCES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
to promote strong bonds to enamel and dentin for a) direct restorative materials such as composite resins, compomers, amalgam, and b) resins cements used in the bonding of indirect restorative materials, such as ceramic veneers, inlays, and crowns.
to seal dentinal tubules
to reduce sensitivity due to exposed tubules in abrasion/erosion lesions of teeth
to promote bonds between incremental layers of composite resins when building a composite restoration
to bond composite resins repairs to ceramics and metals
Device Description
Adhere is an adhesive system used for the bonding of directly and indirectly placed restorative materials to tooth structure. It consists of surface conditioners, primers, an adhesive resin, initiators and accessories for applying the components to tooth surfaces. After tooth conditioning, a primer is applied, and an adhesive resin overlayer is subsequently placed on the surface to interact with restorative materials. Other primers are used for surface reactions with indirect restorative materials.
Ask a Question
Ask a specific question about this device
Page 1 of 1