FDA.reportPublic FDA data

Select Sil Medium Body

Primary DI
17540208000223
Brand
Select Sil Medium Body
Company
Zendo Direct AG
Model
SEL-SIL-MB-SHRS-PNK5
Catalog number
SEL-SIL-MB-SHRS-PNK5
Device description
Super hydrophilic correction impression material based on addition curing vinyl silicones - Medium body, regular set
Published
2017-07-04
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
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17540208000223PackageGS12In Commercial Distribution
07540208000226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1754020800022317540208000223
07540208000226075402080002267540208000226

GMDN Terms#

Term, Definition table
TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage temperature: max. 77°F (25°C)

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456219973JMUJMU DENTAL, INCELW2026-07-07
00840456219980JMUJMU DENTAL, INCELW2026-07-07
00840456219997JMUJMU DENTAL, INCELW2026-07-07
00840456220009JMUJMU DENTAL, INCELW2026-07-07
00840456222232JMUJMU DENTAL, INCELW2026-07-07
00840456222249JMUJMU DENTAL, INCELW2026-07-07
00840456222256JMUJMU DENTAL, INCELW2026-07-07
00840456222263JMUJMU DENTAL, INCELW2026-07-07
00840456222270JMUJMU DENTAL, INCELW2026-07-07
00840456222287JMUJMU DENTAL, INCELW2026-07-07
00840456222294JMUJMU DENTAL, INCELW2026-07-07
00840456222300JMUJMU DENTAL, INCELW2026-07-07
D105VP9008MI4MacImpressSurgimac LLCELW2026-07-06
18016200021546KROMOPAN SIL putty soft (2x300ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021553KROMOPAN SIL putty hard (2x300ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021560KROMOPAN SIL superlight body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021577KROMOPAN SIL superlight body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021584KROMOPAN SIL light body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021591KROMOPAN SIL light body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021607KROMOPAN SIL regular body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021614KROMOPAN SIL regular body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021621KROMOPAN SIL heavy body (2x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021638KROMOPAN SIL heavy body ECONOMY PACK (4x50ml) - NORMAL SETLASCOD SPAELW2026-05-28
18016200021676KROMOPAN SIL putty soft (2x300ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021683KROMOPAN SIL putty hard (2x300ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021690KROMOPAN SIL superlight body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021706KROMOPAN SIL superlight body (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021713KROMOPAN SIL light body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021720KROMOPAN SIL light body ECONOMY PACK (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021737KROMOPAN SIL regular body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28