Home GUDID 17540208000384
Select Calcium Hydroxide Liner LC
Primary DI 17540208000384
Brand Select Calcium Hydroxide Liner LC
Company Zendo Direct AG
Model CAL-LINER
Catalog number CAL-LINER
Device description Light cure radiopaque calcium hydroxide liner - 2 ml syringe
Published 2017-09-26
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 EJK Liner, Cavity, Calcium Hydroxide
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EJK Liner, Cavity, Calcium Hydroxide Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 17540208000384 Package GS1 1 In Commercial Distribution 07540208000387 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 17540208000384 17540208000384 07540208000387 07540208000387 7540208000387
GMDN Terms# Term, Definition table Term Definition Calcium hydroxide dental cement A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., pulp capping, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between calcium hydroxide and salicylic acid (or related esters such as butan-1,3-diol disalicylate). It typically includes some additional fillers/components. After application, this device cannot be reused.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 39 Degrees Fahrenheit 77 Degrees Fahrenheit
Regulatory Flags# DUNS number 486717338 Device count 1 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 07540208000165 Select SE-Bond LC SEL-ETCH-LC-5ml SEL-ETCH-LC-5ml 2017-09-26 07540208000332 Select Supratemp TCB-ST-A3 TCB-ST-A3 2018-04-04 17540208000339 Select Supratemp TCB-ST-A3 TCB-ST-A3 2018-04-04 17540208000391 MTA Capsules ZEN-MTA-UNI ZEN-MTA-UNI 2016-12-15 17540208000407 MTA Firm- Normal Set ZEN-MTA-FRMNSET ZEN-MTA-FRMNSET 2017-11-23 17540208000414 MTA Firm-Fast Set ZEN-MTA-FRMFSTSET ZEN-MTA-FRMFSTSET 2017-11-23 17540208000421 MTA-Flow Fast Set ZEN-MTA-FLOFST ZEN-MTA-FLOFST 2017-11-23 07540208000011 Select Rigid BR RIGBR-LB-SH RIGBR-LB-SH 2017-02-21 07540208000059 Select NanoFill FIL-RS-A1 FIL-RS-A1 2017-07-05 07540208000066 Select NanoFill FIL-RS-A2 FIL-RS-A2 2017-07-05 07540208000073 Select NanoFill FIL-RS-A3 FIL-RS-A3 2017-02-21 07540208000219 Select Sil Light Body SEL-SIL-LB-SHRS-50 SEL-SIL-LB-SHRS-50 2017-02-21 07540208000226 Select Sil Medium Body SEL-SIL-MB-SHRS-PNK5 SEL-SIL-MB-SHRS-PNK5 2017-07-04 07540208000240 Select Sil Heavy Viscosity SEL-SIL-SHRS-GR50 SEL-SIL-SHRS-GR50 2017-02-21 07540208000356 Select Sil Firm Putty SEL-SIL-FR-B400 SEL-SIL-FR-B400 2017-07-05 07540208000370 Select Transbite SELSIL-TRANS-B SELSIL-TRANS-B 2017-11-16 07540208000387 Select Calcium Hydroxide Liner LC CAL-LINER CAL-LINER 2017-09-26 07540208000448 Select Sil Light Body SEL-SIL-LB-SHFS-50 SEL-SIL-LB-SHFS-50 2017-03-07 07540208000455 Select Sil Heavy Viscosity SEL-SIL-SHFS-GR50 SEL-SIL-SHFS-GR50 2017-03-07 07540208000462 Select Sil Medium Body SEL-SIL-MB-SHFS-PNK5 SEL-SIL-MB-SHFS-PNK5 2017-08-09
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