FDA.reportPublic FDA data

KROMALGIN Piu 453g

Primary DI
08033712560229
Brand
KROMALGIN Piu 453g
Company
VANNINI DENTAL INDUSTRY SRL
Model
002000
Catalog number
002000
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
18033712560226PackageGS124In Commercial Distribution
08033712560229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1803371256022618033712560226
08033712560229080337125602298033712560229

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
08033712560236CLIPALGIN 453g0020200020202019-09-06
08033712560250CLIPALGIN 18 g0020250020252019-09-06
08033712560267CROMATIC 18 g0020150020152019-09-06
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

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