Search Results
Found 1 results
510(k) Data Aggregation
K Number
K130680Device Name
ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS
Manufacturer
DENTSOLL, INC.
Date Cleared
2013-07-26
(135 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
DENTSOLL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dentsoll High Dental Denture Resins are intended for manufacturing, relining, repairing, and rebasing of partial or full removable dentures, dental plates, bite plates, personal trays, appliances, occlusal splints and night guards.
Device Description
Dentsoll High Dental Denture Resins are acrylic and polyamide resins for use in creating, relining, repairing, and rebasing denture bases. They are available in clear or pink colors. The Rezen NF and Acrytone resin granules can be used for injection molding and the ISO FAST self curing resin is mixed and applied as a liquid for repairs.
Ask a Question
Page 1 of 1