FDA.reportPublic FDA data

Linea Tac 2000 Manual Amalgamator

Primary DI
00853383006974
Brand
Linea Tac 2000 Manual Amalgamator
Company
Wykle Research, Inc
Model
7020
Published
2016-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00853383006974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853383006974008533830069748533830069740853383006974

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
614557155
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853383006738Wykle Wedges Assorted Sizes 500 count7002016-09-23
00853383006745Wykle Wedges 11mm Natural Color 500 count7112016-09-23
00853383006752Wykle Wedges 13mm Yellow Color 500 count7132016-09-23
00853383006769Wykle Wedges 15mm Blue Color 500 count7152016-09-23
00853383006776Wykle Wedges 17mm Green Color 500 count7172016-09-23
00853383006011Original D Capsules 1 Spill Fast Set 50 count61143-032016-09-23
00853383006158Original D Tablets Fast Set 10 oz174-102016-09-23
00853383006202Original D Capsules 2 Spill Fast Set 100 count61240-032016-09-23
00853383006035Wykalloy Capsules 1 Spill 50 count730002016-09-23
00853383006042Wykalloy Capsules 2 Spill 50 count731002016-09-23
00853383006059Wykalloy Capsules 3 Spill 50 count732002016-09-23
00853383006066Wykalloy Capsules 1 Spill 500 count733002016-09-23
00853383006073Wykalloy Capsules 2 Spill 500 count734002016-09-23
00853383006417Wykalloy amalgam sample pack759012016-12-14
00853383006523ANA 70 Powder 30g11100002018-04-13
00853383006547ANA 70 Powder 250g11102002018-04-13
00853383006554ANA 70 Duett 20011161002018-04-13
00853383006578ANA 70 Powder 500g11103002018-04-13
00853383006585ANA 70 Duett 5011181002018-04-13
00853383006608ANA 70 Duett 40011160002018-04-13

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
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