FDA.reportPublic FDA data

PRESTIGE LIGHT FAST 2 X 50 ML

Primary DI
58033712562167
Brand
PRESTIGE LIGHT FAST 2 X 50 ML
Company
VANNINI DENTAL INDUSTRY SRL
Model
055206
Catalog number
055206
Device description
Vinylpolisiloxane for impressions
Published
2019-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELWMATERIAL, IMPRESSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972027000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972027000ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)Zhermack S.P.A.1997-07-16ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
58033712562167PackageGS129In Commercial Distribution
08033712562162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5803371256216758033712562167
08033712562162080337125621628033712562162

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume100Milliliter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
436650394
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
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
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

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