GIC Mixer 9050

GUDID E22190501

Capsule mixing device

VOCO GmbH

Dental impression material mixer
Primary Device IDE22190501
NIH Device Record Key31c56622-02cb-45b2-931c-b018ef4da13d
Commercial Distribution StatusIn Commercial Distribution
Brand NameGIC Mixer
Version Model Number9050
Catalog Number9050
Company DUNS316699578
Company NameVOCO GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx
Phone999-999-9999
Emailxxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE22190501 [Primary]

FDA Product Code

EFDAmalgamator, Dental, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-18
Device Publish Date2022-03-10

Devices Manufactured by VOCO GmbH

E22162821 - GrandioSO 4U2025-06-10 light-curing, radiopaque nano-hybrid universal composite
E22162831 - GrandioSO 4U2025-06-10 light-curing, radiopaque nano-hybrid universal composite, Kit 5x4.5g
E22162841 - GrandioSO 4U2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A1
E22162851 - GrandioSO 4U2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A2
E22162861 - GrandioSO 4U2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A3
E22162871 - GrandioSO 4U2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A3.5
E22162881 - GrandioSO 4U2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A4
E22162891 - GrandioSO 4U2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, opaque

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.