FDA.report

3M™ Pentamix™

Primary DI
04054596646339
Brand
3M™ Pentamix™
Company
3M Deutschland GmbH
Model
77907
Catalog number
77907
Device description
3M™ Pentamix™ Lite Automatic Mixing Unit - 120V/60Hz NA, 77907
Published
2022-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EFDAMALGAMATOR, DENTAL, AC-POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
EFDAmalgamator, Dental, Ac-PoweredDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04054596646339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04054596646339040545966463394054596646339

GMDN Terms

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

Contacts

PhoneEmail
+1(800)228-39573Mhealthcarecompliance@mmm.com

Regulatory Flags

DUNS number
315731711
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
040545969528123M™ Kerramax Care™PRD500-025PRD500-0252026-01-29
040640350844623M™ Kerramax Care™PRD500-025-B550PRD500-025-B5502026-01-29
040545969528673M™ Kerramax Care™PRD500-050PRD500-0502026-01-29
040545969528983M™ Kerramax Care™PRD500-050-B50PRD500-050-B502026-01-29
040640350845093M™ Kerramax Care™PRD500-050-B550PRD500-050-B5502026-01-29
040545969529423M™ Kerramax Care™PRD500-065PRD500-0652026-01-29
040545969529733M™ Kerramax Care™PRD500-100PRD500-1002026-01-29
040640350845613M™ Kerramax Care™PRD500-100-B550PRD500-100-B5502026-01-29
040545969530243M™ Kerramax Care™PRD500-1174PRD500-11742026-01-29
040545969530793M™ Kerramax Care™PRD500-1175PRD500-11752026-01-29
040545969531093M™ Kerramax Care™PRD500-1176PRD500-11762026-01-29
040545969531303M™ Kerramax Care™PRD500-1177PRD500-11772026-01-29
040545969531613M™ Kerramax Care™PRD500-120PRD500-1202026-01-29
040545969531923M™ Kerramax Care™PRD500-120-B50PRD500-120-B502026-01-29
040545969532223M™ Kerramax Care™PRD500-240PRD500-2402026-01-29
040545969532533M™ Kerramax Care™PRD500-240-B30PRD500-240-B302026-01-29
040545969533143M™ Kerramax Care™PRD500-380-B10PRD500-380-B102026-01-29
040545969533453M™ Kerramax Care™PRD500-380-B30PRD500-380-B302026-01-29
040545969533763M™ Kerramax Care™PRD500-600-B10PRD500-600-B102026-01-29
04035077009386Clinpro™ Glycine Prophy Powder67008670082017-08-04

Other Devices Sharing Product Codes

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
00304040168455Henry ScheinHENRY SCHEIN, INC.EFD2023-03-21
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
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