FDA.reportPublic FDA data

PROMIX one

Primary DI
J00927700010000
Brand
PROMIX one
Company
Renfert GmbH
Model
2770001000
Catalog number
2770001000
Device description
Dental mixer of Surefill one and Calibra Bio capsules, Brand Dentsply Sirona
Published
2023-07-10
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
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
J00927700010000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental amalgam mixerA mains electricity (AC-powered) device used to shake a homogenous mixture of fine dental alloy particles [e.g., tin (Sn), silver (Ag), zinc (Zn), or copper (Cu)] with mercury (Hg) to obtain a dental amalgam, typically right before application. The amalgam is usually prepared in an appropriate capsule that may or may not be an integral part of the device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal105 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity96 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
328502976
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
J00925620010000Dynamix Speed 2256200100025620010002023-07-10
J00927610010000DUOMIX II276100100027610010002023-07-10
J009600010000SYMPRESS60001000600010002023-07-10
J009610010000SYMPRESS II61001000610010002023-07-10
J009660000000temp:ex66000000660000002023-07-10
J009670000000help:ex plaque p67000000670000002023-07-10
J009670000010help:ex plaque p, sample67000001670000012023-07-10
J009670001000help:ex plaque f67000100670001002023-07-10
J009670002000help:ex discolor f67000200670002002023-07-10
J009670010000Sympro67001000670010002023-07-10

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
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
08800000995830OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EFD2022-10-31