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510(k) Data Aggregation
K Number
K082071Device Name
ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT
Manufacturer
Date Cleared
2008-10-02
(72 days)
Product Code
Regulation Number
872.3260Why did this record match?
Applicant Name (Manufacturer) :
ADPHARMA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Desensitizing agent for dentin surfaces by occluding dentin tubules to help prevent microleakage. Use under direct or indirect restorations following dentin etch and province dentin adhesive application. Desensitizing agent for use in treatment of cervical erosion in Class V restorations.
Device Description
AdPharma™ Occlude® Dentin Tubule Agents are for use in one of a number of steps normally involved in the restoration of teeth. This device comes into use following the dentin-etching step and prior to the application of a dentin adhesive or adhesive/primer. The Occlude® is applied to the exposed dentin and the solvent evaporated off, leaving the active glass. It is also anticipated to market Occlude® Dentin Tubule Agents combined with a commercially available, non-aqueous dentin adhesive to condense these two application steps into one step. In vitro testing indicated this combination version is still efficacious. The Occlude® is manufactured in such a way that it is intended to enter the exposed dentin tubules and penetrate to a greater depth than the adhesive itself or adhesive/primer itself.
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