FDA.reportPublic FDA data

ACCUDENT XD

Primary DI
D7076734700
Brand
ACCUDENT XD
Company
IVOCLAR VIVADENT, INC.
Model
673470
Published
2018-03-22
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7076734700PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression material syringe, single-useA non-sterile, hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient?s mouth. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176935203
Device count
1
Lot or batch
true
Expiration date on label
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
D707562862AN0Virtual562862AN562862AN2017-04-07
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

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