FDA.reportPublic FDA data

NAVEX

Primary DI
03770022347045
Brand
NAVEX
Company
MODJAW
Model
NAVEX2
Catalog number
Fiducials (x36)
Device description
Fiducials are the reflective targets fixed on the different trackers (pen, frontal, mandible) and should reflect infra-red light with required intensity.
Published
2022-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NFSDevice, Jaw Tracking, For Monitoring Jaw Positions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFSDevice, Jaw Tracking, For Monitoring Jaw PositionsDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03770022347045PrimaryGS10
03770022347052Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770022347045037700223470453770022347045
03770022347052037700223470523770022347052

GMDN Terms#

Term, Definition table
TermDefinition
Jaw physiology evaluation systemAn assembly of mains electricity (AC-powered) devices designed to record parameters for mandibular and muscles of mastication function, primarily to aid in the diagnosis and treatment of temperomandibular joint (TMJ) and myofascial pain dysfunction (MPD) disorders, and for orthodontic, denture, and reconstruction patient evaluation. It typically uses surface electromyography to evaluate muscle groups at rest or in function; sonography to detect sounds/vibrations from the TMJ joint and/or other computer-based system to non-invasively track the mandible in function or identify its position in space relative to the skull.

Contacts#

Phone, Email table
PhoneEmail
+33482771111support@modjaw.com

Regulatory Flags#

DUNS number
265572589
Device count
36
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770022347212Twin In MotionTWIMTWIM2023-03-03
03770022347250Tech In Motion USTIM US2023-02-09
03770022347007Tech In MotionTIMLTIM Left-handed US2022-02-23
03770022347014Tech In MotionTIMRTech In Motion2022-02-23
03770022347069ForkFORKSForks (x20)2022-02-23
03770022347052NAVEXNAVEX2Fiducials (x36)2022-02-23
03770022347076ForkFORKSForks (x20)2022-02-23
03770022347083Mandibular trackerSMILITMandibular tracker2022-02-23
03770022347106Rear bandTIARA2Rear band2022-02-23
03770022347120Frontal Tracker TIARAFrontal Tracker2022-02-23
03770022347144Pen TrackerTALLYPen Tracker 2022-02-23
03770022347229KIT PATIENT KITKIT2022-02-23

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Primary DI, Brand, Company table
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06970163081489MARATHON®Shining 3D Tech Co., Ltd.NFS2023-10-13
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B915015705701Inductive Charger PlaneAnalyser IIzebris MEDICAL GmbHNFS2023-10-04
06970163081229Opera System®Shining 3D Tech Co., Ltd.NFS2023-08-23
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B915011700410ARCUSdigma 3 USBzebris MEDICAL GmbHNFS2023-07-20
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B915011700720PlaneAnalyser II USBzebris MEDICAL GmbHNFS2023-07-20
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B915015700231Tizian JMA Optic USBzebris MEDICAL GmbHNFS2023-07-20
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B915019602500Para-occlusal Attachment with Lip Archzebris MEDICAL GmbHNFS2023-07-13
B915019602510Para-occlusal Attachment with Lip Arch AGzebris MEDICAL GmbHNFS2023-07-13
B915019602550Para-occlusal Attachment with Support Surfacezebris MEDICAL GmbHNFS2023-07-13
B915019602560Para-occlusal Attachment with Support Surface AGzebris MEDICAL GmbHNFS2023-07-13
B915019602600Para-occlusal Attachmentzebris MEDICAL GmbHNFS2023-07-13
B915019602800Occlusal Attachment UNzebris MEDICAL GmbHNFS2023-07-13
B915019603300Bite Fork Type SI / Fusion Bitezebris MEDICAL GmbHNFS2023-07-13
B915019603410Bite Fork PS1 zebris MEDICAL GmbHNFS2023-07-13
B915019603600Bite Fork UN zebris MEDICAL GmbHNFS2023-07-13
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