Home GUDID EBRE540012709
flow.sil Assortment
Primary DI EBRE540012709
Brand flow.sil Assortment
Company bredent GmbH & Co. KG
Model 54001270
Catalog number 54001270
Device description flow.sil Assortment 10 parts 1 Assortment
Published 2023-09-07
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false
Product Codes# Code, Name table Code Name EFX PROTECTOR, SILICATE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EFX Protector, Silicate Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status EBRE540012709 Package HIBCC 1 Not in Commercial Distribution EBRE540012700 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Denture reliner, soft, professional A denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a soft, plastic condition. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.
Regulatory Flags# DUNS number 341086190 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 EBRE540012700 flow.sil Assortment bredent GmbH & Co. KG EFX 2023-09-07 00810000529179 BluSep™ PARKELL, INC. EFX 2020-02-07