Home GUDID D00262380162 Dycal® Ivory Radiopaque Calcium Hydroxide Composition
Primary DI D00262380162
Brand Dycal® Ivory Radiopaque Calcium Hydroxide Composition
Company DENTSPLY INTERNATIONAL INC.
Model 623801
Catalog number 623801
Device description Dycal® Ivory Radiopaque Calcium Hydroxide Composition, Standard Package
Published 2016-09-23
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 EJK LINER, CAVITY, CALCIUM HYDROXIDE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EJK Liner, Cavity, Calcium Hydroxide Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D00262380162 Package HIBCC 6 In Commercial Distribution D0026238011 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dental composite resin A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Weight 11 Gram Weight 13 Gram
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep out of direct sunlight.
Regulatory Flags# DUNS number 083235549 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit true 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 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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