Home GUDID 00816594021884 SURE ETCH
Primary DI 00816594021884
Brand SURE ETCH
Company DANVILLE MATERIALS, LLC
Model 89463
Catalog number 89463
Device description SURE ETCH,GEL,5ML,REFILL
Published 2016-06-22
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 EBF MATERIAL, TOOTH SHADE, RESIN
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EBF Material, Tooth Shade, Resin Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816594021884 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 00816594021884 00816594021884 816594021884 0816594021884
GMDN Terms# Term, Definition table Term Definition Light-cured dental restorative composite resin A dental restorative material that consists of a blend of filler particles (e.g., glass, ceramic, zirconia, silica) mixed with a synthetic, photo-polymerizable, organic resin matrix [e.g., bisphenol A-glycidyl methacrylate (BISGMA), urethane dimethacrylate (UDMA)] intended to fill dental cavities or restore damaged hard dental tissue. It is typically a one-part paste, contained within an application syringe or capsule, that requires a light source of specific wavelengths (e.g., 460 to 480 nm) to initiate resin polymerization/hardening post application; it is typically available in tooth-coloured shades. After application, this device cannot be reused.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 74 Degrees Fahrenheit
Regulatory Flags# DUNS number 601302743 Device count 1 DM exempt true Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true 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 00815967025856 Rodin Pac-Dent, Inc. EBF 2026-03-24 00815967025863 Rodin Pac-Dent, Inc. EBF 2026-03-24 00815967025870 Rodin Pac-Dent, Inc. EBF 2026-03-24 00815967021438 OptiComp Pac-Dent, Inc. EBF 2026-03-23 00815967021797 OptiComp Pac-Dent, Inc. EBF 2026-03-23 00815967027447 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028161 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028178 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028185 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028192 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028208 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028215 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028222 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028239 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028246 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028253 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028260 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028277 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028284 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028291 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028307 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028314 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028321 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028338 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028345 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028352 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028369 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028376 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028383 Rodin Pac-Dent, Inc. EBF 2026-03-23 00815967028390 Rodin Pac-Dent, Inc. EBF 2026-03-23
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