FDA.reportPublic FDA data

Henry Schein

Primary DI
00304040168455
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5702251
Catalog number
5702251
Device description
Capsule Mixer Henry Schein
Published
2023-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00304040168455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040168455003040401684553040401684550304040168455

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040195437Henry Schein570582457058242026-03-17
00304040195444Henry Schein570582557058252026-03-17
00304040195420Henry Schein570582357058232026-03-13
00304040187463Zirlux920004692000462026-02-04
00304040187470Zirlux920004792000472026-02-04
00304040187487Zirlux920004892000482026-02-04
00304040187517Zirlux920005192000512026-02-04
00304040187524Zirlux920005292000522026-02-04
00304040187531Zirlux920005392000532026-02-04
00304040187548Zirlux920005492000542026-02-04
00304040187555Zirlux920005592000552026-02-04
00304040187562Zirlux920005692000562026-02-04
00304040187579Zirlux920005792000572026-02-04
00304040187586Zirlux920005892000582026-02-04
00304040187593Zirlux920005992000592026-02-04
00304040187616Zirlux920006192000612026-02-04
00304040187623Zirlux920006292000622026-02-04
00304040187647Zirlux920006392000632026-02-04
00304040187654Zirlux920006492000642026-02-04
00304040187661Zirlux920006592000652026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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 USHeraeus Kulzer 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
08800000995830OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EFD2022-10-31
14548161336956CAPSULE MIXER CM-IIGc America Inc.EFD2022-10-11
EDMG9994821MixStar eMotionDMG Chemisch-Pharmazeutische Fabrik GmbHEFD2022-09-01
EDMG9995671MixStar-Tips WhiteDMG Chemisch-Pharmazeutische Fabrik GmbHEFD2022-09-01
040545966463393M™ Pentamix™3M Deutschland GmbHEFD2022-08-29
040545966466293M™ RotoMix™3M Deutschland GmbHEFD2022-08-29
040545967357293M™ Pentamix™3M Deutschland GmbHEFD2022-08-29
00366975036230EONBENCO DENTAL SUPPLY CO.EFD2022-08-04
040545966463223M™ Imprint™3M Deutschland GmbHEFD2022-08-02
040545967357053M™ ESPE™ Impregum™ Penta™3M Deutschland GmbHEFD2022-08-02
00889813033210Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFD2022-05-02
00889813033227Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFD2022-05-02
E22190501GIC MixerVOCO GmbHEFD2022-03-10
DVIV602286WU1Silamat S6IVOCLAR VIVADENT AKTIENGESELLSCHAFTEFD2020-11-11
00866709000402VIALMIX®RFIDLANTHEUS MEDICAL IMAGING, INC.EFD2020-09-15
00304040117422Henry Schein MaximaHENRY SCHEIN, INC.EFD2019-11-26