FDA.reportPublic FDA data

ECCO

Primary DI
08964003163587
Brand
ECCO
Company
B. Ali Impex
Model
102436
Device description
ECCO - Luxury Magnetic 3-Dimensional Articulator 1pk
Published
2024-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
EJPArticulators

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJPArticulatorsDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08964003163587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08964003163587089640031635878964003163587

GMDN Terms#

Term, Definition table
TermDefinition
Dental articulatorA hinged, mechanical, dental device designed to simulate the movement of a patient's upper and lower jaws and onto which maxillary and mandibular casts or models are attached according to a pre-recorded intermaxillary relationship. It is designed to simulate all or part of the mandibular movements and is used for, e.g., examination, diagnosis, or to construct dental appliances. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"
Ethylene Oxide;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
645802117
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08964003163853Doctor Nice786-28L102024-01-29
08964003163860Doctor Nice786-30L102024-01-29
08964003163877Doctor Nice786-04G32024-01-29
08964003163884Doctor Nice786-04L2024-01-29
08964003163891Doctor Nice786-03L2024-01-29
08964003163075Doctor Nice786-14786-142023-11-10
08964003163112Doctor Nice786-14G42023-11-10
08964003163129Doctor Nice786-33G22023-11-10
08964003163136Doctor Nice786-34G22023-11-10
08964003163143Doctor Nice786-14G52023-11-10
08964003163020Doctor Nice786-012023-11-09
08964003163037Doctor Nice786-022023-11-09
08964003163051Doctor Nice786-032023-11-09
08964003163068Doctor Nice786-152023-11-09
08964003163082Doctor Nice786-15/G22023-11-09
08964003163099Doctor Nice786-14/G22023-11-09
08964003163105Doctor Nice786-15G42023-11-09
08964003163150Doctor Nice786-04LB2023-11-09
08964003163167Doctor Nice786-282023-11-09
08964003163174Doctor Nice786-302023-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D040342160MA2340 W/STRAPSWHIP-MIX CORPORATIONEJP2025-09-11
00348783005813W.O.W.™PREMIER DENTAL PRODUCTS COMPANYEJP2024-06-06
00348783005820W.O.W.™PREMIER DENTAL PRODUCTS COMPANYEJP2024-06-06
00348783005837W.O.W.™PREMIER DENTAL PRODUCTS COMPANYEJP2024-06-06
00348783005844W.O.W.™PREMIER DENTAL PRODUCTS COMPANYEJP2024-06-06
00348783005851W.O.W.™ 2PREMIER DENTAL PRODUCTS COMPANYEJP2024-06-06
D040200113770Denar Mark 310 ArticulatorWHIP-MIX CORPORATIONEJP2024-02-27
D040200113780Denar Mark 320 ArticulatorWHIP-MIX CORPORATIONEJP2024-02-27
D040200114080Denar Mark 330 ArticulatorWHIP-MIX CORPORATIONEJP2024-02-27
08800075601490OSUNG MNDOSUNG MND Co., Ltd.EJP2024-02-22
08964003163570Doctor NiceB. Ali ImpexEJP2024-01-29
E1997592331ArticulatorCandulor AGEJP2023-10-18
00816063020677iTero Articulator KitAlign Technology, Inc.EJP2021-06-04
E23550700HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
E23550710HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
E23550730HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
E23550740HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
E23550750HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
E23550760HANDY IIMSHOFU DENTAL CORPORATIONEJP2021-02-03
D0400033020001Hanau 96 H2 ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400098560001Hanau-Mate Non-Adjustable ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400108850001Hanau Wide-Vue ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400141020001Hanau modular ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400141160001Hanau modular ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400143000001Hanau modular ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400143090001Hanau modular ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400145030001Hanau modular ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400224614640 Q ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400226712240 ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400227814641 ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22