Home GUDID D002634354K1 Self Cure Activator
Primary DI D002634354K1
Brand Self Cure Activator
Company DENTSPLY INTERNATIONAL INC.
Model 634354K
Catalog number 634354K
Device description Self Cure Activator Refill Package
Published 2022-09-22
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name KLE AGENT, TOOTH BONDING, RESIN
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KLE Agent, Tooth Bonding, Resin Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D002634354K1 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dentine bonding agent/set A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Allow material to reach room temperature prior to use. Special Storage Condition, Specify 0 0 Do not freeze. Special Storage Condition, Specify 0 0 Do not use after expiration date. Special Storage Condition, Specify 0 0 Inadequate storage conditions will shorten the shelf life and may lead to the product malfunctioning. Special Storage Condition, Specify 0 0 Keep out of direct sunlight and store in a well ventilated place at room temperature not exceeding 25° C. Special Storage Condition, Specify 0 0 Protect from moisture. Special Storage Condition, Specify 0 0 Refrigerated storage is not required, but is acceptable when not in use. Storage Environment Temperature 2 Degrees Celsius 24 Degrees Celsius
Regulatory Flags# DUNS number 083235549 Device count 1 Lot or batch true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D0026243451 Enhance® mini Finishing System 624345 624345 2022-04-11 D0026243551 Enhance® mini Finishing System 624355 624355 2022-04-11 D0026243651 Enhance® mini Finishing System 624365 624365 2022-04-11 D0026243751 Enhance® mini Finishing System 624375 624375 2022-10-13 D0026243851 Enhance® mini Finishing System 624385 624385 2022-04-11 D002624550001 Polytrays 62455000 62455000 2022-07-07 D002624550011 Polytrays 62455001 62455001 2022-07-07 D002624550021 Polytrays 62455002 62455002 2022-07-07 D002624551001 Polytrays 62455100 62455100 2022-07-07 D002624551011 Polytrays 62455101 62455101 2022-07-07 D002624551021 Polytrays 62455102 62455102 2022-07-07 D002624551031 Polytrays 62455103 62455103 2022-07-07 D002624551051 Polytrays 62455105 62455105 2022-07-07 D0026076071 Calibra® Bio Bioceramic Luting Cement 607607 607607 2022-04-20 D0026590301 Palodent® Sectional Matrix System 659030 659030 2019-04-02 D0026590701 Palodent® Sectional Matrix System 659070 659070 2019-04-02 D0026631001 AutoMate® 663100 663100 2019-04-02 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
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