FDA.reportPublic FDA data

Zenith

Primary DI
D033099610331
Brand
Zenith
Company
DMG AMERICA, LLC
Model
099-61033
Catalog number
099-61033
Device description
Zenith Variable Speed Dental Amalgamator 120V
Published
2022-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
D033099610331PrimaryHIBCC0

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
201-894-5505gvazquez@dmg-america.com

Regulatory Flags#

DUNS number
106792427
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00325047000005DMG2206002206002025-11-06
D0337884101Kolorz Prophylaxis Paste7884102025-06-04
D0337884111Kolorz Prophylaxis Paste7884112025-06-04
D0337884100Kolorz Prophylaxis Paste7884102025-06-04
D0337884110Kolorz Prophylaxis Paste7884112025-06-04
D0331430200TEMP TABS1430202025-04-18
D0331430330TEMP TABS1430332025-04-18
D033003619011ZenithDental61901003-619012016-09-23
D033003610961Zekrya Gingival Protector Kit003-61096003-610962022-12-12
D033003610971Zekrya Small Arc003-61097003-610972022-12-12
D033003610981Zekrya Large Arc003-61098003-610982022-12-12
D0337884011Kolorz Prophylaxis Paste7884017884012022-12-12
D0337884021Kolorz Prophylaxis Paste7884027884022022-12-12
D0337884031Kolorz Prophylaxis Paste7884037884032022-12-12
D0337884041Kolorz Prophylaxis Paste7884047884042022-12-12
D0337884061Kolorz Prophylaxis Paste7884067884062022-12-12
D0337884071Kolorz Prophylaxis Paste7884077884072022-12-12
D0337884081Kolorz Prophylaxis Paste7884087884082022-12-12
D0337884091Kolorz Prophylaxis Paste7884097884092022-12-12
D0337884151Kolorz Prophylaxis Paste7884157884152022-12-12

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