FDA.reportPublic FDA data

GIC Mixer

Primary DI
E22190501
Brand
GIC Mixer
Company
VOCO GmbH
Model
9050
Catalog number
9050
Device description
Capsule mixing device
Published
2022-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFDAmalgamator, Dental, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFDAmalgamator, Dental, Ac-PoweredDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E22190501PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression material mixerA mains electricity (AC-powered) device designed for mixing to produce a dental impression material chairside immediately before application to the oral cavity of a patient during a dental procedure. It is typically used to blend a salt of alginic acid (i.e., alginate) with water (and appropriate additives if necessary) to produce a dental impression material of rapid irreversible setting. The device typically consists of an electrical mixer with a well, a container (e.g., cup) used to mix the alginate with water before placing in the mixer well, and external controls to operate the mixer.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
999-999-9999xxx@xx.xx

Regulatory Flags#

DUNS number
316699578
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E22122661VOCO Profluorid Varnish + BioMin226622662026-05-06
E22122671VOCO Profluorid Varnish + BioMin226722672026-05-06
E22122681VOCO Profluorid Varnish + BioMin226822682026-05-06
E22122691VOCO Profluorid Varnish + BioMin226922692026-05-06
E22122701VOCO Profluorid Varnish + BioMin227022702026-05-06
E22122711VOCO Profluorid Varnish + BioMin227122712026-05-06
E22122721VOCO Profluorid Varnish + BioMin227222722026-05-06
E22122731VOCO Profluorid Varnish + BioMin227322732026-05-06
E22122741VOCO Profluorid Varnish + BioMin227422742026-05-06
E22122761VOCO Profluorid Varnish + BioMin227622762026-05-06
E22122771VOCO Profluorid Varnish + BioMin227722772026-05-06
E22122781VOCO Profluorid Varnish + BioMin227822782026-05-06
E22122791VOCO Profluorid Varnish + BioMin227922792026-05-06
E22163141Grandio disc multicolor631463142026-04-30
E22163151Grandio disc multicolor631563152026-04-30
E22163161Grandio disc multicolor631663162026-04-30
E22163171Grandio disc multicolor631763172026-04-30
E22163181Grandio disc multicolor631863182026-04-30
E22163191Grandio disc multicolor631963192026-04-30
E22163231Grandio disc multicolor632363232026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998022579Solventum™Solventum Germany GmbHEFD2026-05-08
040545967341423M™ Penta™3M Deutschland GmbHEFD2026-05-08
040545967342273M™ Penta™3M Deutschland GmbHEFD2026-05-08
040545967361773M™ Impregum™3M Deutschland GmbHEFD2026-05-08
040545967363443M™ Imprint™3M Deutschland GmbHEFD2026-05-08
040545967363513M™ Imprint™3M Deutschland GmbHEFD2026-05-08
040545967363683M™ Impregum™3M Deutschland GmbHEFD2026-05-08
040545967363753M™ Impregum™3M Deutschland GmbHEFD2026-05-08
040545967365663M™ Imprint™3M Deutschland GmbHEFD2026-05-08
040545967366033M™ Penta™3M Deutschland GmbHEFD2026-05-08
E22190521GIC Mixer IIVOCO GmbHEFD2026-03-02
09336472005474ULTRAMAT 2SDI LIMITEDEFD2026-02-16
09336472005535ULTRAMAT SSDI LIMITEDEFD2026-02-16
14719871634322Biodentine MixerSEPTODONT SAS SPECIALITES SEPTODONTEFD2025-04-25
00359883000608PowerMix™ Automatic Impression Material DispenserDEN-MAT HOLDINGS, LLCEFD2025-03-12
06974267890688COXOFoshan COXO Medical Instrument Co.,Ltd.EFD2024-12-18
J014660937560Dynamix Speed 2 USKulzer GmbHEFD2024-09-09
00304040186084Henry ScheinHENRY SCHEIN, INC.EFD2024-08-07
00304040186091Henry ScheinHENRY SCHEIN, INC.EFD2024-08-07
J00925620010000Dynamix Speed 2Renfert GmbHEFD2023-07-10
J00927610010000DUOMIX IIRenfert GmbHEFD2023-07-10
J00927700010000PROMIX oneRenfert GmbHEFD2023-07-10
J009600010000SYMPRESSRenfert GmbHEFD2023-07-10
J009610010000SYMPRESS IIRenfert GmbHEFD2023-07-10
00304040168455Henry ScheinHENRY SCHEIN, INC.EFD2023-03-21
008171690235483D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEFD2022-12-29
04719871633311Biodentine MixerSEPTODONT SAS SPECIALITES SEPTODONTEFD2022-12-13
D033099550161TechnoDMG AMERICA, LLCEFD2022-12-09
D033099551181TechnoDMG AMERICA, LLCEFD2022-12-09
D033099610331ZenithDMG AMERICA, LLCEFD2022-12-09