Home GUDID D0016882110 Lucitone® 199
Primary DI D0016882110
Brand Lucitone® 199
Company Dentsply International Inc.
Model 540-Unit Powder
Catalog number 688211
Device description Light
Published 2017-02-10
Public version status Update
Distribution status 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 EBI RESIN, DENTURE, RELINING, REPAIRING, REBASING
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EBI Resin, Denture, Relining, Repairing, Rebasing Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D0016882110 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dental appliance fabrication material, resin A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.
Device Sizes# Type, Value, Unit table Type Value Unit Weight 25 Pound
Regulatory Flags# DUNS number 606173334 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true 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
Other Devices Sharing Product Codes# 
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