Home GUDID EHAR70836311 Harvard PremiumFlow OptiTips B2
Primary DI EHAR70836311
Brand Harvard PremiumFlow OptiTips B2
Company Harvard Dental International GmbH
Model 7083631
Device description Flowable light cure nano-hybrid composite for restorations
Published 2016-10-24
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 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 EHAR70836311 Primary HIBCC 0 7083631 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 4 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 341553293 Device count 20 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 EHAR70837011 Harvard PremiumSil Light 7083701 2016-09-15 EHAR70837021 Harvard PremiumSil Light Fast 7083702 2016-09-15 EHAR70837111 Harvard PremiumSil Medium 7083711 2016-09-15 EHAR70837121 Harvard PremiumSil Medium Fast 7083712 2016-09-15 EHAR70837211 Harvard PremiumSil Mono 7083721 2016-09-15 EHAR70837221 Harvard PremiumSil Mono Fast 7083722 2016-09-15 EHAR70837311 Harvard PremiumSil Heavy 7083731 2016-09-15 EHAR70837321 Harvard PremiumSil Heavy Fast 7083732 2016-09-15 EHAR70837331 Harvard PremiumSil Heavy MaxiMix 7083733 2016-09-15 EHAR70837401 Harvard PremiumSil Putty Soft MaxiMix 7083740 2016-09-15 EHAR70837411 Harvard PremiumSil Putty Soft 7083741 2016-09-15 EHAR70837421 Harvard PremiumSil Putty Soft Fast 7083742 2016-09-15 EHAR70837511 Harvard PremiumSil Putty 7083751 2016-09-15 EHAR70837521 Harvard PremiumSil Putty Fast 7083752 2016-09-15 EHAR177081 Harvard Temp Cem 17708 2016-09-15 EHAR177201 Harvard Implant Semi-permanent 17720 2016-09-15 EHAR177221 Harvard Temp C&B A2 17722 2016-09-15 EHAR177241 Harvard ZirconCore A3 17724 2016-09-15 EHAR177271 Harvard Ionoresin Fill OptiCaps A2 17727 2016-09-18 EHAR177291 Harvard Ionoglas Fill Extra OptiCaps A2 17729 2016-09-18
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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