FDA.reportPublic FDA data

DeltaFil Conditioner

Primary DI
EDMG5400201
Brand
DeltaFil Conditioner
Company
DMG Chemisch-Pharmazeutische Fabrik GmbH
Model
540020
Catalog number
540020
Device description
DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFilchemically bonds to enamel and dentine and releases fluoride ions. It is available in the shadesA1, A2, A3 and A4 based on the Vita color system and White and Dark. Each capsule contains a minimumusable amount of 0.13 ml.DeltaFil Conditioner is an aqueous polyacrylic acid solution for treating the smear layerfollowing preparation and for conditioning the cavity, which optimizes the bonding of DeltaFilto the tooth’s structure.DeltaFil Conditioner1 Bottle @ 7.7 ml (8g)
Published
2022-06-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDMG5400201PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Glass ionomer dental cementA 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
TypeLowHighCondition
Special Storage Condition, Specify00Dark and dry
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
201-894-5505ccosta@dmg-america.com

Regulatory Flags#

DUNS number
320744915
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

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EDMG1105870Luxatemp® Fluorescence1105871105872016-09-21
EDMG1105880Luxatemp® Fluorescence1105881105882016-09-21
EDMG1105890Luxatemp® Fluorescence1105891105892016-09-21
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EDMG1107190Luxatemp® Fluorescence1107191107192016-09-23
EDMG1107220Luxatemp® Fluorescence1107221107222016-09-23
EDMG1107230Luxatemp® Fluorescence1107231107232016-09-23
EDMG2123841LuxaBond - Total Etch2123842123842016-09-23
EDMG2133201TECO2133202133202016-09-22
EDMG2130801Vitique2130802130802016-09-22

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