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
00197998118654Solventum™ Promogran Prisma™MA032MA0322026-04-10
00197998175190Solventum™ Promogran Prisma™PS2123PS21232026-04-10
00197998291128Solventum™ Promogran Prisma™MA123MA1232026-04-10
00197998291166Solventum™ Promogran Prisma™MA028MA0282026-04-10
00197998291203Solventum™ Promogran Prisma™PS2028PS20282026-04-10
00197998018930Solventum™36716367162026-05-08
00197998018947Solventum™36717367172026-05-08
00197998024252Solventum™69940699402026-05-08
00197998024269Solventum™41928419282026-05-08
00197998024276Solventum™41925419252026-05-08
00197998024290Solventum™41926419262026-05-08
00197998024306Solventum™69952699522026-05-08
00197998024313Solventum™69951699512026-05-08
00197998024320Solventum™69950699502026-05-08
00197998024337Solventum™69949699492026-05-08
00197998024344Solventum™69946699462026-05-08
00197998024351Solventum™69945699452026-05-08
00197998024368Solventum™69944699442026-05-08
00197998024375Solventum™69941699412026-05-08
00197998024382Solventum™69942699422026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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
08800000995830OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.EFD2022-10-31