FDA.reportPublic FDA data

KROMALGIN Piu 300x18g

Primary DI
00803371256102
Brand
KROMALGIN Piu 300x18g
Company
VANNINI DENTAL INDUSTRY SRL
Model
002003
Catalog number
002003
Device description
Alginate for dental impressions
Published
2019-07-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe

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
00803371256263PackageGS1300Not in Commercial Distribution
00803371256102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00803371256263008033712562638033712562630803371256263
00803371256102008033712561028033712561020803371256102

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
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
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
08033712560267CROMATIC 18 g0020150020152019-09-06
08033712560274KROMALGIN Piu 18g0020030020032019-09-19
08033712560335PROTESIL CHROMATIC 500g0050110050112019-09-06
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
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