Home GUDID EDMG5400040 DeltaFil
Primary DI EDMG5400040
Brand DeltaFil
Company DMG Chemisch-Pharmazeutische Fabrik GmbH
Model 540004
Catalog number 540004
Device description DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil chemically bonds to enamel and dentine and releases fluoride ions. It is available in the shades A1, A2, A3, A3.5 and A4 based on the Vita color system. Each capsule contains a minimum usable amount of 0.13 ml. DeltaFil Conditioner is an aqueous polyacrylic acid solution for treating the smear layer following preparation and for conditioning the cavity, which optimizes the bonding of DeltaFil to the tooth’s structure. DeltaFil 50 Applicap @ 370 mg powder, 75 mg liquid (0.07 ml), Shade A4 (DeltaFil Conditioner 1 Bottle @ 7.7 ml (8g))
Published 2022-06-13
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name EMA Cement, Dental
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EMA Cement, Dental Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status EDMG5400041 Primary HIBCC 0 EDMG5400040 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Glass ionomer dental cement A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Dry Storage Environment Temperature 15 Degrees Celsius 25 Degrees Celsius Storage Environment Temperature 59 Degrees Fahrenheit 77 Degrees Fahrenheit
Regulatory Flags# DUNS number 320744915 Device count 50 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number true 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 EDMG1103600 Luxatemp® Automix Solar 110360 110360 2016-09-21 EDMG1103680 Luxatemp® Automix Plus 110368 110368 2016-09-21 EDMG1104000 Luxatemp® Automix Plus 110400 110400 2016-09-21 EDMG1104010 Luxatemp® Automix Plus 110401 110401 2016-09-21 EDMG1104020 Luxatemp® Automix Plus 110402 110402 2016-09-21 EDMG1104030 Luxatemp® Automix Plus 110403 110403 2016-09-21 EDMG1104040 Luxatemp® Automix Plus 110404 110404 2016-09-21 EDMG1104060 Luxatemp® Automix Plus 110406 110406 2016-09-21 EDMG1105850 Luxatemp® Fluorescence 110585 110585 2016-09-21 EDMG1105860 Luxatemp® Fluorescence 110586 110586 2016-09-21 EDMG1105870 Luxatemp® Fluorescence 110587 110587 2016-09-21 EDMG1105880 Luxatemp® Fluorescence 110588 110588 2016-09-21 EDMG1105890 Luxatemp® Fluorescence 110589 110589 2016-09-21 EDMG1107100 Luxatemp® Fluorescence 110710 110710 2016-09-21 EDMG1107190 Luxatemp® Fluorescence 110719 110719 2016-09-23 EDMG1107220 Luxatemp® Fluorescence 110722 110722 2016-09-23 EDMG1107230 Luxatemp® Fluorescence 110723 110723 2016-09-23 EDMG2123841 LuxaBond - Total Etch 212384 212384 2016-09-23 EDMG2133201 TECO 213320 213320 2016-09-22 EDMG2130801 Vitique 213080 213080 2016-09-22
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