Home GUDID EDMG9997658 O-Bite
Primary DI EDMG9997658
Brand O-Bite
Company DMG Chemisch-Pharmazeutische Fabrik GmbH
Model 999765
Catalog number 999765
Device description Bite registration material automix system. Fresh hardness for optimal occlusion. Content: 4 cartridges @50ml paste, Accessories
Published 2016-09-22
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 ELW Material, Impression
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ELW Material, Impression Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status EDMG9997651 Package HIBCC 4 In Commercial Distribution EDMG9997658 Package HIBCC 6 In Commercial Distribution EDMG9997650 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Silicone dental impression material An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 59 Degrees Fahrenheit 77 Degrees Fahrenheit
Regulatory Flags# DUNS number 320744915 Device count 1 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
Other Devices Sharing Product Codes# 
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