Home GUDID D0026344020 Dentsply Sirona
Primary DI D0026344020
Brand Dentsply Sirona
Company DENTSPLY INTERNATIONAL INC.
Model 634402
Catalog number 634402
Device description Amalgam Bonding Accessory Kit
Published 2022-08-16
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 D0026344020 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.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Amalgam Bonding Accessory Kit adhesive should be stored wiht the original caps only. Special Storage Condition, Specify 0 0 Keep out of direct sunlight, and store in a well-ventilated place at room temperature. Special Storage Condition, Specify 0 0 Protect from moisture. Do not freeze. Do not use after expiration date. Special Storage Condition, Specify 0 0 Refrigerated storage is not required but is acceptable when not in use. Allow material to reach room temperature prior to use. Storage Environment Temperature 2 Degrees Celsius 24 Degrees Celsius
Regulatory Flags# DUNS number 083235549 Device count 1 Kit true 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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