Home GUDID D79339200041 Axcent Acrylics
Primary DI D79339200041
Brand Axcent Acrylics
Company GARRECO, LLC
Model 3920004
Catalog number 3920004
Device description ACR MON #6 TRAY LIQUID (4 OZ EACH)
Published 2016-09-25
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 true Product Codes# Code, Name table Code Name EBH Material, Impression Tray, Resin
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EBH Material, Impression Tray, Resin Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D79339200041 Package HIBCC 4 In Commercial Distribution D79339200040 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dental impression tray material A material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The tray is typically made by applying the material to a preliminary plaster or stone model of the patient's teeth and gums. The material is used in cases in which a preformed impression tray is not suitable. This is a single-use device.
Regulatory Flags# DUNS number 364004762 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published D080XXTRR05KGXXW050 TrinDy Try-In YAMAHACHI DENTAL MFG.,CO. EBH 2026-04-27 D080XXTRR05KGXXXA10 TrinDy Try-In YAMAHACHI DENTAL MFG.,CO. EBH 2026-04-27 D080XXTRR05KGXXXA20 TrinDy Try-In YAMAHACHI DENTAL MFG.,CO. EBH 2026-04-27 D080XXTRRX1KGXXW050 TrinDy Try-In YAMAHACHI DENTAL MFG.,CO. EBH 2026-04-27 D080XXTRRX1KGXXXA10 TrinDy Try-In YAMAHACHI DENTAL MFG.,CO. EBH 2026-04-27 D080XXTRRX1KGXXXA20 TrinDy Try-In YAMAHACHI DENTAL MFG.,CO. EBH 2026-04-27 D080XXTRT05KGXXBLU0 TrinDy Tray YAMAHACHI DENTAL MFG.,CO. EBH 2026-04-27 D080XXTRT05KGXXPNK0 TrinDy Tray YAMAHACHI DENTAL MFG.,CO. EBH 2026-04-27 D080XXTRTX1KGXXBLU0 TrinDy Tray YAMAHACHI DENTAL MFG.,CO. EBH 2026-04-27 D080XXTRTX1KGXXPNK0 TrinDy Tray YAMAHACHI DENTAL MFG.,CO. EBH 2026-04-27 00197998216121 Clarity™ Solventum Orthodontics Corporation EBH 2026-04-25 00197998216138 Clarity™ Solventum Orthodontics Corporation EBH 2026-04-25 00197998216152 Clarity™ Solventum Orthodontics Corporation EBH 2026-04-25 00197998216169 Clarity™ Solventum Orthodontics Corporation EBH 2026-04-25 00197998216176 Clarity™ Solventum Orthodontics Corporation EBH 2026-04-25 09359215000376 DentaTRAY Orange ASIGA PTY LTD EBH 2025-01-17 08800017902043 Disposable Impression Bite Tray DXM CO., LTD EBH 2024-06-11 08800017902074 Disposable Impression Bite Tray DXM CO., LTD EBH 2024-06-11 D248628000 Surfactant 32oz HAGER WORLDWIDE, INC. EBH 2023-07-13 D248628011 Surfactant 8oz HAGER WORLDWIDE, INC. EBH 2023-07-13 20386040012710 COE® Gc America Inc. EBH 2023-04-20 20386040012727 COE® Gc America Inc. EBH 2023-04-20 20386040012734 COE® Gc America Inc. EBH 2023-04-20 20386040012741 COE® Gc America Inc. EBH 2023-04-20 20386040012758 COE® Gc America Inc. EBH 2023-04-20 20386040012765 COE® Gc America Inc. EBH 2023-04-20 20386040012772 COE® Gc America Inc. EBH 2023-04-20 20386040012789 COE® Gc America Inc. EBH 2023-04-20 20386040012796 COE® Gc America Inc. EBH 2023-04-20 40386040001886 COE® Gc America Inc. EBH 2023-04-20