FDA.reportPublic FDA data

I-SIL Bite Registration SP

Primary DI
08809262959871
Brand
I-SIL Bite Registration SP
Company
Spident Co., Ltd.
Model
102-0102
Catalog number
102-0102
Device description
Vinyl Polysiloxane Impression Material
Published
2017-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00002022092100PackageGS1120In Commercial Distribution
00202103119027PackageGS150In Commercial Distribution
02020070318117PackageGS125In Commercial Distribution
08809262959871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00002022092100000020220921000020220921000002022092100
00202103119027002021031190272021031190270202103119027
02020070318117020200703181172020070318117
08809262959871088092629598718809262959871

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
201-944-0511Spident.usa@gmail.com

Regulatory Flags#

DUNS number
689370711
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809262953602EsCemEsCem A22026-04-29
08809262953619EsCemEsCem A32026-04-29
08809262953626EsCemEsCem TW2026-04-29
08809262959000Temro.FlowTemp it Flow+ yellow 4ea2026-04-28
08809262959017Temro.FlowTemp it Flow+ Blu 4ea2026-04-28
08809262953206EsCom250EsCom250 A1#3203A12026-04-21
08809262953213EsCom250EsCom250 A2#3203A22026-04-21
08809262953220EsCom250EsCom250 A3#3203A32026-04-21
08809262953237EsCom250EsCom250 A3.5#3203A352026-04-21
08809262953244EsCom250EsCom250 A4#3203A42026-04-21
08809262953251EsCom250EsCom250 B1#3203B12026-04-21
08809262953268EsCom250EsCom250 B2#3203B22026-04-21
08809262953275EsCom250EsCom250 C2#3203C22026-04-21
08809262953282EsCom250EsCom250 D2#3203D22026-04-21
08809262953299EsCom250EsCom250 G1#3203G12026-04-21
08809262953305EsCom250EsCom250 AO2#3203AO22026-04-21
08809262953312EsCom250EsCom250 AO3#3203AO32026-04-21
08809262953329EsCom250EsCom250 TW#3203TW2026-04-21
08809262953336EsCom250EsCom250 Capsule A1 20ea#3203A1PCA2026-04-21
08809262953343EsCom250EsCom250 Capsule A2 20ea#3203A2PCA2026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
18016200021744KROMOPAN SIL regular body (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021751KROMOPAN SIL heavy body (2x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021768KROMOPAN SIL heavy body ECONOMY PACK (4x50ml) - FAST SETLASCOD SPAELW2026-05-28
18016200021805KROMOPAN SIL MONO - monofase (2x50ml)LASCOD SPAELW2026-05-28
18016200021843KromopanSil Bite 2x50mlLASCOD SPAELW2026-05-28
18016200010298IQ - alginato non cromatico verde tipo 1 (24x450g)LASCOD SPAELW2026-05-27
18016200010496IQ TROPICAL - alginato cromatico tipo 1 (24x450g)LASCOD SPAELW2026-05-27
18016200010748IQ - alginato chrom viola/lilla/verde tipo 1 (24x450g)LASCOD SPAELW2026-05-27
18016200011318Mono7LASCOD SPAELW2026-05-27
07640181478934AFFINISColtène/Whaledent AGELW2022-03-27
07640181478958AFFINISColtène/Whaledent AGELW2022-03-27
07640181478972AFFINISColtène/Whaledent AGELW2022-03-27
07640181479030AFFINISColtène/Whaledent AGELW2022-03-27