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
CodeName
EJKLiner, Cavity, Calcium Hydroxide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJKLiner, Cavity, Calcium HydroxideDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17540208000384PackageGS11In Commercial Distribution
07540208000387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1754020800038417540208000384
07540208000387075402080003877540208000387

GMDN Terms#

Term, Definition table
TermDefinition
Calcium hydroxide dental cementA 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
TypeLowHighCondition
Storage Environment Temperature39 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

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 DIBrandModelCatalogPublished
07540208000165Select SE-Bond LCSEL-ETCH-LC-5mlSEL-ETCH-LC-5ml2017-09-26
07540208000332Select SupratempTCB-ST-A3TCB-ST-A32018-04-04
17540208000339Select SupratempTCB-ST-A3TCB-ST-A32018-04-04
17540208000391MTA CapsulesZEN-MTA-UNIZEN-MTA-UNI2016-12-15
17540208000407MTA Firm- Normal SetZEN-MTA-FRMNSETZEN-MTA-FRMNSET2017-11-23
17540208000414MTA Firm-Fast SetZEN-MTA-FRMFSTSETZEN-MTA-FRMFSTSET2017-11-23
17540208000421MTA-Flow Fast SetZEN-MTA-FLOFSTZEN-MTA-FLOFST2017-11-23
07540208000011Select Rigid BRRIGBR-LB-SHRIGBR-LB-SH2017-02-21
07540208000059Select NanoFill FIL-RS-A1FIL-RS-A12017-07-05
07540208000066Select NanoFill FIL-RS-A2FIL-RS-A22017-07-05
07540208000073Select NanoFill FIL-RS-A3FIL-RS-A32017-02-21
07540208000219Select Sil Light BodySEL-SIL-LB-SHRS-50SEL-SIL-LB-SHRS-502017-02-21
07540208000226Select Sil Medium BodySEL-SIL-MB-SHRS-PNK5SEL-SIL-MB-SHRS-PNK52017-07-04
07540208000240Select Sil Heavy ViscositySEL-SIL-SHRS-GR50SEL-SIL-SHRS-GR502017-02-21
07540208000356Select Sil Firm PuttySEL-SIL-FR-B400SEL-SIL-FR-B4002017-07-05
07540208000370Select TransbiteSELSIL-TRANS-BSELSIL-TRANS-B2017-11-16
07540208000387Select Calcium Hydroxide Liner LCCAL-LINERCAL-LINER2017-09-26
07540208000448Select Sil Light BodySEL-SIL-LB-SHFS-50SEL-SIL-LB-SHFS-502017-03-07
07540208000455Select Sil Heavy ViscositySEL-SIL-SHFS-GR50SEL-SIL-SHFS-GR502017-03-07
07540208000462Select Sil Medium BodySEL-SIL-MB-SHFS-PNK5SEL-SIL-MB-SHFS-PNK52017-08-09

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