DeltaFil Conditioner 540020

GUDID EDMG5400201

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 Conditioner 1 Bottle @ 7.7 ml (8g)

DMG Chemisch-Pharmazeutische Fabrik GmbH

Glass ionomer dental cement
Primary Device IDEDMG5400201
NIH Device Record Keyeff9435d-bd5e-479d-a413-198b157c308f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDeltaFil Conditioner
Version Model Number540020
Catalog Number540020
Company DUNS320744915
Company NameDMG Chemisch-Pharmazeutische Fabrik GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com
Phone201-894-5505
Emailccosta@dmg-america.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Dark and dry
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Dark and dry
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Dark and dry
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Dark and dry
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Dark and dry
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Dark and dry
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Dark and dry
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Dark and dry
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Dark and dry
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Dark and dry
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Dark and dry
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Dark and dry
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Dark and dry
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Dark and dry
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Dark and dry
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Dark and dry
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Dark and dry
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Dark and dry
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Dark and dry
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Dark and dry
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEDMG5400201 [Primary]

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-21
Device Publish Date2022-06-13

Devices Manufactured by DMG Chemisch-Pharmazeutische Fabrik GmbH

EDMG2228291 - Safetip Dispenser Pro2024-07-22 Dispenser for direct application with all commercially available composite tips. e. g. suitable for Ecosite Elements.
EDMG2229010 - Ecosite One2023-11-30 Ecosite One is a light-curing, radiopaque composite for direct fillings, especially suitable for use in the posterior region.
EDMG2229020 - Ecosite One2023-11-30 Ecosite One is a light-curing, radiopaque composite for direct fillings, especially suitable for use in the posterior region.
EDMG2229001 - Ecosite One2023-11-29 Ecosite One is a light-curing, radiopaque composite for direct fillings, especially suitable for use in the posterior region.
EDMG5400050 - DeltaFil2022-11-07 DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil chemically bonds to enamel and de
EDMG5400060 - DeltaFil2022-11-07 DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil chemically bonds to enamel and de
EDMG5400100 - DeltaFil2022-11-07 DeltaFil is a radiopaque, classic glass ionomer restorative material in capsule form. DeltaFil chemically bonds to enamel and de
EDMG1102661 - Automix-Tips Blue 1:12022-09-09 Automix-Tips Blue 1:1. Suitable for: PermaCem Automix, PermaCem Automix Dual, TempoCem Automix, TempoCem NE Automix. Content: 50

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.