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510(k) Data Aggregation
K Number
K152861Device Name
Aquasil Ultra + Smart Wetting Impression Material
Manufacturer
DENTPLY INTERNATIONAL INC.
Date Cleared
2016-03-04
(156 days)
Product Code
ELW
Regulation Number
872.3660Why did this record match?
Applicant Name (Manufacturer) :
DENTPLY INTERNATIONAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Aquasil® Ultra + Smart Wetting® Impression Material is indicated for all dental impression techniques.
Device Description
Aquasil® Ultra+ Smart Wetting® Impression Material is a quadrafunctional hydrophilic addition reaction silicone elastomeric dental impression material with excellent hydrophilic properties, dimensional accuracy, high tear strength, and resistance to permanent deformation.
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