FDA.reportPublic FDA data

KromopanSil Bite 2x50ml

Primary DI
18016200021843
Brand
KromopanSil Bite 2x50ml
Company
LASCOD SPA
Model
KRS095
Device description
Bite registration silicone 2x50ml plus mixing tips
Published
2026-05-28
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
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201184000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201184000Lascod Impression MaterialsLascod Spa2020-05-05ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18016200021843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1801620002184318016200021843

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.

Regulatory Flags#

DUNS number
436269609
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
18016200021546KROMOPAN SIL putty soft (2x300ml) - NORMAL SETKRS0102026-05-28
18016200021553KROMOPAN SIL putty hard (2x300ml) - NORMAL SETKRS0202026-05-28
18016200021560KROMOPAN SIL superlight body (2x50ml) - NORMAL SETKRS0402026-05-28
18016200021577KROMOPAN SIL superlight body ECONOMY PACK (4x50ml) - NORMAL SETKRS0442026-05-28
18016200021584KROMOPAN SIL light body (2x50ml) - NORMAL SETKRS0502026-05-28
18016200021591KROMOPAN SIL light body ECONOMY PACK (4x50ml) - NORMAL SETKRS0542026-05-28
18016200021607KROMOPAN SIL regular body (2x50ml) - NORMAL SETKRS0602026-05-28
18016200021614KROMOPAN SIL regular body ECONOMY PACK (4x50ml) - NORMAL SETKRS0642026-05-28
18016200021621KROMOPAN SIL heavy body (2x50ml) - NORMAL SETKRS0702026-05-28
18016200021638KROMOPAN SIL heavy body ECONOMY PACK (4x50ml) - NORMAL SETKRS0742026-05-28
18016200021676KROMOPAN SIL putty soft (2x300ml) - FAST SETKRS5102026-05-28
18016200021683KROMOPAN SIL putty hard (2x300ml) - FAST SETKRS5202026-05-28
18016200021690KROMOPAN SIL superlight body (2x50ml) - FAST SETKRS5402026-05-28
18016200021706KROMOPAN SIL superlight body (4x50ml) - FAST SETKRS5442026-05-28
18016200021713KROMOPAN SIL light body (2x50ml) - FAST SETKRS5502026-05-28
18016200021720KROMOPAN SIL light body ECONOMY PACK (4x50ml) - FAST SETKRS5542026-05-28
18016200021737KROMOPAN SIL regular body (2x50ml) - FAST SETKRS5602026-05-28
18016200021744KROMOPAN SIL regular body (4x50ml) - FAST SETKRS5642026-05-28
18016200021751KROMOPAN SIL heavy body (2x50ml) - FAST SETKRS5702026-05-28
18016200021768KROMOPAN SIL heavy body ECONOMY PACK (4x50ml) - FAST SETKRS5742026-05-28

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
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
08800024203805Delikit 3.0 Light BodySherpakoreaELW2022-09-15
07640181478934AFFINISColtène/Whaledent AGELW2022-03-27
07640181478958AFFINISColtène/Whaledent AGELW2022-03-27
07640181478972AFFINISColtène/Whaledent AGELW2022-03-27
07640181479030AFFINISColtène/Whaledent AGELW2022-03-27