FDA.reportPublic FDA data

Virtual

Primary DI
D707562862AN0
Brand
Virtual
Company
IVOCLAR VIVADENT, INC.
Model
562862AN
Catalog number
562862AN
Published
2017-04-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
D707562862AN0PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176935203
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D707562826AN0Virtual562826AN562826AN2017-04-07
D707562852AN0Virtual562852AN562852AN2017-04-07
D707562853AN0Virtual562853AN562853AN2017-04-07
D707562854AN0Virtual562854AN562854AN2017-04-07
D707562855AN0Virtual562855AN562855AN2017-04-07
D707562858AN0Virtual562858AN562858AN2017-04-07
D707562859AN0Virtual562859AN562859AN2017-04-07
D707573527EN0Virtual573527AN573527AN2017-04-07
D707573524EN0Virtual573524AN573524AN2017-04-07
D7075797970Aquarius XH5797975797972018-10-29
D7075797990Aquarius XH5797995797992018-10-29
D7075798020Aries5798025798022018-10-29
D7075798040Aries5798045798042018-10-29
D7075798060Aries5798065798062018-10-29
D7075798740BioUniversal PKF5798745798742018-10-29
D7075798760BioUniversal PKF5798765798762018-10-29
D7075798960Capricorn5798965798962018-10-29
D7075798980Capricorn5798985798982018-10-29
D7075799000Capricorn5799005799002018-10-29
D7075799210d SIGN 845799215799212018-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056640080997Ormadent PuttyMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081093OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081109OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081161OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081185OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081598Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081604Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081611Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081642Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081666Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081673Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081734Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081741Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081802Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081819Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081826Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081833Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081925Ormalab 85MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081994Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082007Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082014Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082038Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082601Ormalab 85MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082991AlginmajorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083042AlginmajorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083080AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083134AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083141AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083196AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083202AlginkidMAJOR PRODOTTI DENTARI SPAELW2026-10-20