Home GUDID D870S979520 EasyGum Strip
Primary DI D870S979520
Brand EasyGum Strip
Company Harvest Dental Products, LLC
Model 9802
Device description EasyGum™ Strip LC Comp, 4/pk, Original Pink
Published 2024-06-06
Public version status New
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 EBI Resin, Denture, Relining, Repairing, Rebasing
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EBI Resin, Denture, Relining, Repairing, Rebasing Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D870980224 Primary HIBCC 0 D870S979520 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dental composite resin A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.
Regulatory Flags# DUNS number 794668751 Device count 2 DM exempt false Premarket exempt false 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D87097961 Harvest EasyGum 9796 9796 2026-01-20 D87097941 Harvest EasyGum 9794 9794 2026-01-05 D87010035161 Harvest Esthetic DCL Denture 10035-16 10035-16 2025-10-27 D87010035201 Harvest Esthetic DCL Denture 10035-20 10035-20 2025-10-27 D87010035251 Harvest Esthetic DCL Denture 10035-25 10035-25 2025-10-27 D870980011 EasyGum Strip 9800 9800 2024-10-03 D87098401 EasyGum Strip - Modifier 9840 9840 2024-09-10 D87098421 EasyGum Strip - Modifier 9842 9842 2024-09-10 D87098441 EasyGum Strip - Modifier 9844 9844 2024-09-10 D87098461 EasyGum Strip - Modifier 9846 9846 2024-09-10 D87098481 EasyGum Strip - Modifier 9848 9848 2024-09-10 D87098501 EasyGum Strip - Modifier 9850 9850 2024-09-10 D87098521 EasyGum Strip - Modifier 9852 9852 2024-09-10 D87098541 EasyGum Strip - Modifier 9854 9852 2024-09-10 D87098561 EasyGum Strip - Modifier 9856 9856 2024-09-10 D87098581 EasyGum Strip - Modifier 9858 9858 2024-09-10 D87098601 EasyGum Strip - Modifier 9860 9860 2024-09-10 D87097972 EasyGum Strip 9797 9797 2024-07-23 D870980426 EasyGum Strip 9804 9804 2024-07-23 D870980628 EasyGum Strip 9806 9806 2024-07-23
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