FDA.reportPublic FDA data

ACCUDENT XD

Primary DI
D7076798901
Brand
ACCUDENT XD
Company
IVOCLAR VIVADENT, INC.
Model
679890
Catalog number
679890
Device description
AccuDent XD Syringe
Published
2022-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIDSyringe, Restorative And Impression MaterialDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7076798901PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression material syringe, reusableA 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 reusable device.

Regulatory Flags#

DUNS number
176935203
Device count
1
Premarket exempt
true
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
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
10304040194789Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10304040194796Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10304040194802Henry ScheinHENRY SCHEIN, INC.EID2026-01-20
10371347019886Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-12-30
10371347017783Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2025-11-18
08800017902203DX-MixerDXM CO., LTDEID2025-09-29
08056000372298Dynamic-static Mixing TipsZHERMACK SPAEID2025-03-28
08056000372304Mixing TipsZHERMACK SPAEID2025-03-28
08056000372311Mixing TipsZHERMACK SPAEID2025-03-28
08056000372328Mixing TipsZHERMACK SPAEID2025-03-28
J014656875140IOT white 96Kulzer GmbHEID2024-09-09
J014660007820IOT yellow 96Kulzer GmbHEID2024-09-09
J014660009050BITE REG INTRAORAL TIP CD 96Kulzer GmbHEID2024-09-09
J014660019880Mixing Tip yellow 1:1 48Kulzer GmbHEID2024-09-09
J014660019890Mixing Tip green 1:1 48Kulzer GmbHEID2024-09-09
08800017901923DX-MixerDXM CO., LTDEID2024-06-04
08800017901978DX-MixerDXM CO., LTDEID2024-06-04
08800017902005DX-MixerDXM CO., LTDEID2024-06-04
08800017902029DX-MixerDXM CO., LTDEID2024-06-04
10810339032064SAFE DENTBGSS Company Inc.EID2024-05-01
07615208353730Clinical Accessory (no MD)IVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-10-25
08800017901893Dynamic MixerDXM CO., LTDEID2023-10-25
08800017901879Dynamic MixerDXM CO., LTDEID2023-10-24
08800017901848DX-MixerDXM CO., LTDEID2023-07-31
08800017901657DX-MixerDXM CO., LTDEID2023-07-26
00020221017809EXEL 1mL CARRYING AND DELIVERY SYRINGEExel InternationalEID2023-04-21
07615208339932CannulaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-03-23
07615208379297CannulaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEID2023-03-23
10371347010845Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2023-02-15
10371347008620Advance Dental ProductsThe Atlanta Dental Supply CompanyEID2023-02-10