FDA.reportPublic FDA data

Solventum™

Primary DI
00197998022579
Brand
Solventum™
Company
Solventum Germany GmbH
Model
76310
Catalog number
76310
Device description
Solventum™ Rotating Capsule Mixing Device, 76310, 1 EA
Published
2026-05-08
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
00197998022579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998022579001979980225791979980225790197998022579

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)634-2249regulatoryrequests@solventum.com

Regulatory Flags#

DUNS number
315518329
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197998326615Solventum™ Adaptic™MAD003MAD0032026-08-26
00197998326653Solventum™ Adaptic™MAD042MAD0422026-08-26
00197998367281Solventum™ Adaptic™MAD013MAD0132026-08-26
00197998367359Solventum™ Adaptic™MAD023MAD0232026-08-26
00197998367427Solventum™ Adaptic™MAD062MAD0622026-08-26
00197998152252Solventum™ Tegaderm™90600906002026-08-23
00197998152283Solventum™ Tegaderm™90601906012026-08-23
00197998152313Solventum™ Tegaderm™90602906022026-08-23
00197998152344Solventum™ Tegaderm™90603906032026-08-23
00197998152375Solventum™ Tegaderm™90604906042026-08-23
00197998305801Solventum™ Tegaderm™90817908172026-08-23
00197998305832Solventum™ Tegaderm™90815908152026-08-23
00197998305863Solventum™ Tegaderm™90805908052026-08-23
00197998305894Solventum™ Tegaderm™90803908032026-08-23
00197998305924Solventum™ Tegaderm™90802908022026-08-23
00197998305955Solventum™ Tegaderm™90801908012026-08-23
00197998305986Solventum™ Tegaderm™90800908002026-08-23
00197998415500Solventum™ Tegaderm™90613906132026-08-23
00197998415548Solventum™ Tegaderm™90611906112026-08-23
00197998415586Solventum™ Tegaderm™90612906122026-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04548162373847AccuMix Ampule MixerSHOFU DENTAL CORPORATIONEFD2026-07-17
09336472033439Dentsply Sirona MixerSDI LIMITEDEFD2026-07-03
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