FDA.reportPublic FDA data

KROMOPAN SIL light body ECONOMY PACK (4x50ml) - FAST SET

Primary DI
18016200021720
Brand
KROMOPAN SIL light body ECONOMY PACK (4x50ml) - FAST SET
Company
LASCOD SPA
Model
KRS554
Device description
KROMOPAN SIL light body ECONOMY PACK (4x50ml) - FAST SET no mix tips included
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
18016200021720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1801620002172018016200021720

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
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
18016200021805KROMOPAN SIL MONO - monofase (2x50ml)KRS4002026-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800024201986Implant Heavy BodySherpakoreaELW2023-08-03
08800024201948Precisil BigSherpakoreaELW2021-06-14
08800024201931Delikit Premium Light BodySherpakoreaELW2021-01-27
08800024201924Precisil Heavy Body FSSherpakoreaELW2021-01-25
08800024201900Delikit Light BodySherpakoreaELW2021-01-07
08800024201917Delikit Light Body FSSherpakoreaELW2021-01-07
08800024201887Delikit Heavy Body FSSherpakoreaELW2021-01-04
08800024201894Delikit Bite RegistrationSherpakoreaELW2021-01-04
08800024201870Delikit Medium BodySherpakoreaELW2020-12-21
08800024201863Deli-Bite ClearSherpakoreaELW2020-10-13
08800024201849Imflex Light BodySherpakoreaELW2020-09-18
08800024201856Imflex Putty RSSherpakoreaELW2020-09-18
08800024201825Jackpot LB FastSherpakoreaELW2020-07-23
08800024201832Jackpot LB FastSherpakoreaELW2020-07-23
08800024201795Delikit Putty RSSherpakoreaELW2020-05-12
08800024201801Delikit Putty FSSherpakoreaELW2020-05-12
08800024201696Delikit Light BodySherpakoreaELW2020-04-29
08800024201702Delikit Light BodySherpakoreaELW2020-04-29
08800024201719Delikit Light Body FSSherpakoreaELW2020-04-29
08800024201726Delikit Light Body FSSherpakoreaELW2020-04-29
08800024201733Delikit Plant Heavy BodySherpakoreaELW2020-04-29
08800024201740Delikit Plant Heavy BodySherpakoreaELW2020-04-29
08800024201757Delikit Plant Light BodySherpakoreaELW2020-04-29
08800024201764Delikit Plant Light BodySherpakoreaELW2020-04-29
08800024201771Delikit Extra Light BodySherpakoreaELW2020-04-29
08800024201788Delikit Jumbo MonophaseSherpakoreaELW2020-04-29
08800024201665Delikit Heavy BodySherpakoreaELW2020-04-27
08800024201672Delikit Heavy Body FSSherpakoreaELW2020-04-27
08800024201689Delikit Heavy Body FSSherpakoreaELW2020-04-27
08800024201580Imflex Heavy BodySherpakoreaELW2020-04-08