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
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