Home GUDID D002678876122 Aquasil Ultra Heavy Fast Set Smart Wetting® Impression Material
Primary DI D002678876122
Brand Aquasil Ultra Heavy Fast Set Smart Wetting® Impression Material
Company DENTSPLY INTERNATIONAL INC.
Model 678876
Catalog number 678876
Device description Aquasil Ultra Heavy FS 2-Pack Cartridge Refill Case (12)
Published 2016-09-21
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name ELW MATERIAL, IMPRESSION
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ELW Material, Impression Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D002678876122 Package HIBCC 12 Not in Commercial Distribution D0026788761 Primary HIBCC 0 D0026788760 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Silicone dental impression material An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Total Volume 50 Milliliter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep away from direct sunlight. Keep dry.
Regulatory Flags# DUNS number 083235549 Device count 2 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D0013010121 Ceramco® 3 Powder Opaque i2/i4 301012 2016-09-21 D0013010211 Ceramco® 3 Powder Opaque D2 301021 2016-09-21 D0013010311 Ceramco® 3 Powder Opaque Modifier Yellow 301031 2016-09-21 D0013010321 Ceramco® 3 Powder Opaque Modifier Sienna 301032 2016-09-21 D0013010361 Ceramco® 3 Powder Opaque Modifier Pink 301036 2016-09-21 D0013010371 Ceramco® 3 Powder Opaque Modifier Ochre 301037 2016-09-21 D0013010481 Ceramco® 3 Paste Opaque A3.5 301048 2016-09-21 D0013010591 Ceramco® 3 Paste Opaque C2 301059 2016-09-21 D0013010701 Ceramco® 3 Paste Opaque Modifiers White 301070 2016-09-21 D0013011031 Ceramco® 3 Opaceous Dentin i1 301103 2016-09-21 D0013011071 Ceramco® 3 Opaceous Dentin A3.5 301107 2016-09-21 D0013011101 Ceramco® 3 Opaceous Dentin i6 301110 2016-09-21 D0013011181 Ceramco® 3 Opaceous Dentin C2 301118 2016-09-21 D0013011221 Ceramco® 3 Opaceous Dentin D3 301122 2016-09-21 D0013011501 Ceramco® 3 Dentin C4 301150 2016-09-21 D0013011611 Ceramco® 3 Dentin Modifier A3.5 301161 2016-09-21 D0013011671 Ceramco® 3 Dentin Modifier Blue 301167 2016-09-21 D0013012001 Ceramco® 3 Natural Enamel White 301200 2016-09-21 D0013012011 Ceramco® 3 Natural Enamel Extra Light 301201 2016-09-21 D0013013221 Ceramco® 3 Overglaze 301322 2016-09-21
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