FDA.reportPublic FDA data

CROMATIC 18 g

Primary DI
08033712560267
Brand
CROMATIC 18 g
Company
VANNINI DENTAL INDUSTRY SRL
Model
002015
Catalog number
002015
Device description
Alginate for dental impressions
Published
2019-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

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
38033712560268PackageGS1300In Commercial Distribution
08033712560267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3803371256026838033712560268
08033712560267080337125602678033712560267

GMDN Terms#

Term, Definition table
TermDefinition
Alginate dental impression materialA material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume27280Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Handling Environment Temperature
Storage Environment Temperature4 Degrees Celsius28 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+39055644698info@vanninidental.com

Regulatory Flags#

DUNS number
436650394
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033712560212CROMATIC 453g0020100020102019-09-06
08033712560229KROMALGIN Piu 453g0020000020002019-09-06
08033712560236CLIPALGIN 453g0020200020202019-09-06
08033712560250CLIPALGIN 18 g0020250020252019-09-06
08033712560274KROMALGIN Piu 18g0020030020032019-09-19
08033712560335PROTESIL CHROMATIC 500g0050110050112019-09-06
00803371256102KROMALGIN Piu 300x18g0020030020032019-07-31
08033712562810PRESTIGE MIXING TIPS YELLOW 48 PCS0580160580162019-09-06
08033712562865PRESTIGE MIXING TIPS GREEN 48 PCS0580150580152019-09-06
08033712562872PRESTIGE INTRA-ORAL TIPS 48 PCS0580040580042019-09-06
08033712562193PRESTIGE REGULAR 2 X 50 ML0552050552052019-09-06
08033712562858DISPENSER0510300510302019-09-06
08033712560311PROTESIL ELASTIC RAPID 500g0050020050022019-09-06
08033712560328PROTESIL NORMAL RIGID 500g0050060050062019-09-06
08033712561158PROTESIL INDURENT GEL 60 ML0560210560212019-09-06
08033712562032PRESTIGE PUTTY SOFT 300 ml +300ml0550020550022019-09-06
08033712562056PRESTIGE LIGHT FAST 2X50 ML+12 YELLOW MIXING TIPS0551060551062019-09-06
08033712562100PRESTIGE REGULAR 2X50 ML+12 YELLOW MIXING TIPS0551050551052019-09-06
08033712562155PRESTIGE BITE CAD CAM 2X50 ML+12 GREEN MIXING TIPS0550150550152019-09-06
08033712562162PRESTIGE LIGHT FAST 2 X 50 ML0552060552062019-09-06

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