FDA.report

Articulator

Primary DI
E1997592331
Brand
Articulator
Company
Candulor AG
Model
759233
Catalog number
759233
Device description
Articulator CA 3.0 LARGE
Published
2023-10-18
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

Product Codes

CodeName
EJPARTICULATORS

Product Code Classifications

CodeDeviceSpecialtyClass
EJPArticulatorsDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E1997592331PrimaryHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
480467422
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07630813462219TCR Mono7562037562032025-05-20
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07630813439259Candulor Preference5784225784222023-11-16

Other Devices Sharing Product Codes

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
08964003163570Doctor NiceB. Ali ImpexEJP2024-01-29
08964003163587ECCOB. Ali ImpexEJP2024-01-29
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
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D0400098560001Hanau-Mate Non-Adjustable ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
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D0400227814641 ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22
D0400227914641 Q ArticulatorWHIP-MIX CORPORATIONEJP2020-09-22