Home GUDID 00841549115998 InstaTemp® Max Temp. Material 4:1 Dispensing gun
Primary DI 00841549115998
Brand InstaTemp® Max Temp. Material 4:1 Dispensing gun
Company STERNGOLD DENTAL LLC
Model 220221
Device description A dispensing gun used for Instatemp Max composite, a tooth colored bis-acryl composite used to fabricate temporary crowns and bridges, long-term temporaries, provisional inlays, onlays and veneers.
Published 2023-07-18
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name EBG Crown And Bridge, Temporary, Resin EIY Instrument, Filling, Plastic, Dental
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EBG Crown And Bridge, Temporary, Resin Dental 2 EIY Instrument, Filling, Plastic, Dental Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841549115998 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00841549115998 00841549115998 841549115998 0841549115998
GMDN Terms# Term, Definition table Term Definition Dental material cartridge-plunging applicator, two-component, manual A hand-held manual device intended to dispense a two-component dental material (e.g., impression material) [not included] from a cartridge directly into the mouth or into another device (e.g., impression tray). It is typically a pistol-like device with a cartridge-plunging mechanism; typically, a dental material mixing nozzle is attached to the distal tip of the cartridge during use. This is a reusable device after appropriate cleaning.
Regulatory Flags# DUNS number 124763728 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00841549118517 SternTek Duplicating Material 222012 2023-10-04 00841549101823 ERA® DO LP Basic Kit w/ Tools SS 811412 2020-07-07 00841549115042 Sterngold Implant System Cortical Bone Drill 3.2mm 905522 2020-07-07 00841549103841 ERA® Implant Abutment Micro 0°, 4mm Cuff (AX) 812435 2017-03-21 00841549103889 ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (BD) 812532 2017-03-21 00841549103896 ERA® Implant Abutment Micro Ang. Base, 3mm Cuff (BD) 812533 2017-03-21 00841549103902 ERA® Implant Abutment Micro Ang. Base, 4mm Cuff (BD) 812534 2017-03-21 00841549103919 ERA® Implant Abutment Micro Ang. Base, 5mm Cuff (BD) 812535 2017-03-21 00841549103926 ERA® Implant Abutment Micro Ang. Base, 6mm Cuff (BD) 812536 2017-03-21 00841549103933 ERA® Implant Abutment Micro 0°, 0.5mm Cuff (BD) 812537 2017-03-21 00841549103940 ERA® Implant Abutment Micro 0°, 2mm Cuff (BD) 812538 2017-03-21 00841549103957 ERA® Implant Abutment Micro 0°, 3mm Cuff (BD) 812539 2017-03-21 00841549103964 ERA® Implant Abutment Micro 0°, 4mm Cuff (BD) 812540 2017-03-21 00841549103988 ERA® Implant Abutment Micro 0°, 6mm Cuff (BD) 812542 2017-03-22 00841549103995 ERA® Implant Abutment Micro Ang. Base, 1mm Cuff (BE) 812543 2017-03-22 00841549104008 ERA® Implant Abutment Micro Ang. Base, 2mm Cuff (BE) 812544 2017-03-22 00841549104015 ERA® Implant Abutment Micro Ang. Base, 3mm Cuff (BE) 812545 2017-03-22 00841549104022 ERA® Implant Abutment Micro Ang. Base, 4mm Cuff (BE) 812546 2017-03-22 00841549104039 ERA® Implant Abutment Micro Ang. Base, 5mm Cuff (BE) 812547 2017-03-22 00841549104046 ERA® Implant Abutment Micro Ang. Base, 6mm Cuff (BE) 812548 2017-03-22
Other Devices Sharing Product Codes# 
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