FDA.reportPublic FDA data

Vacu-Mixer Automated VPS Mixing Machine

Primary DI
00850211006205
Brand
Vacu-Mixer Automated VPS Mixing Machine
Company
HO DENTAL COMPANY LLC
Model
Vacu-Mixer
Device description
Vacu-Mixer VPS Automated Mixing Machine, Hand Held, Rechargeable, Portable,Uses 120cc Cartridges, Comes with Stand, Adapter/Charger
Published
2017-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850211006205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850211006205008502110062058502110062050850211006205

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

Regulatory Flags#

DUNS number
012676012
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850211006144Facial Plane RelatorFPR-1022023-05-17
00850211006229Dynamic Mixing TipsVacu-Mixer Tip2017-10-10
00850211006021Vaccu-sil VPS Heavy Body 50 Impression MaterialRegular Set2017-10-10
00850211006038Vaccu-sil VPS Heavy Body 50 Impression MaterialFast Set2017-10-10
00850211006045Vaccu-sil VPS Light Body CartridgeFast Set2017-10-10
00850211006052Vaccu-sil VPS Light Body CartridgeRegular Set2017-10-10
00850211006083Harmony Anterior Disposable Dual Arch TrayAnterior2017-10-10
00850211006090Harmony Posterior Disposable Dual Arch TryPosterior2017-10-10
00850211006212Mojo VPS Light Body Impression SyringeEmpty2017-10-10
00850211006236Vaccu-sil VPS Heavy Body 120 Impression MaterialFast Set2017-10-10
00850211006243Vaccu-sil VPS Heavy Body 120 Impression MaterialRegular Set2017-10-10
00850211006250Vaccu-sil Bite RegistrationRegular Set2017-10-10
00850211006267Vaccu-Sil Mojo Complete Light Body SyringeRegular Set2017-10-10
00850211006274Vaccu-Sil Mojo Complete Light Body SyringeFast Set2017-10-10
00850211006311VacuCord Gingival Retraction CordSize 002017-10-11
00850211006328VacCord Gingival Retraction CordSize 02017-10-11
00850211006335VacuCord Gingival Retraction CordSize 12017-10-11
00850211006342VacuCord Gingival Retraction CordSize 22017-10-11

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Primary DI, Brand, Company table
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040545967342273M™ Penta™3M Deutschland GmbHEFD2026-05-08
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J00925620010000Dynamix Speed 2Renfert GmbHEFD2023-07-10
J00927610010000DUOMIX IIRenfert GmbHEFD2023-07-10
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00304040168455Henry ScheinHENRY SCHEIN, INC.EFD2023-03-21
008171690235483D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEFD2022-12-29
04719871633311Biodentine MixerSEPTODONT SAS SPECIALITES SEPTODONTEFD2022-12-13
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