FDA.reportPublic FDA data

JT-3D

Primary DI
00860003499917
Brand
JT-3D
Company
Bio-Research Associates, Inc.
Model
NR 16 Channel
Device description
The Jaw Tracker-3D is a non-invasive, non-painful test that records incisor-point movements in three dimensions. A small magnet, attached to the labial surfaces of the mandibular incisors, is tracked to produce vertical, anteroposterior, and lateral movement data. Jaw tracking can assist in designing optimal chewing patterns as well as detecting abnormal functions which can aid in more accurate diagnosis. It also assists in recording accurate, reproducible “bite registrations.”
Published
2023-06-22
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
NFSDevice, Jaw Tracking, For Monitoring Jaw Positions

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952218000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952218000JT-3 ELECTROGNATHOGRAPHBio-Research Associates, Inc.1995-09-21NFS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003499917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003499917008600034999178600034999170860003499917

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4143577525info@bioresearchinc.com

Regulatory Flags#

DUNS number
063501373
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009598201Taylor IndustriesLong Term Monitoring Electrode2023-08-17
00860003499900BioEMGIII NRG V22023-06-22
00860003499924BioJVAAmplifier 1608FS2023-06-22
00860003499931BioJVAHeadset2023-06-22
00860003499948BioPAK92023-06-22
00860003499955M-ScanRest2023-06-22
00860003499962M-ScanClench2023-06-22
00860003499979QuadraTENSUnit2023-06-22
00860009598218BioJVAAmplifier USB-2312023-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970163085968SHINING 3D®Shining 3D Tech Co., Ltd.NFS2025-05-23
06970163087672SHINING 3D®Shining 3D Tech Co., Ltd.NFS2025-05-23
06970163084213SHINING 3D®Shining 3D Tech Co., Ltd.NFS2025-03-15
06970163081489MARATHON®Shining 3D Tech Co., Ltd.NFS2023-10-13
B915015705101Inductive Charger JMA-Opticzebris MEDICAL GmbHNFS2023-10-04
B915015705201Inductive Charger Tizian JMA-Opticzebris MEDICAL GmbHNFS2023-10-04
B915015705401Inductive Charger ARCUSdigma IIIzebris MEDICAL GmbHNFS2023-10-04
B915015705501Inductive Charger zebris for ceramillzebris MEDICAL GmbHNFS2023-10-04
B915015705701Inductive Charger PlaneAnalyser IIzebris MEDICAL GmbHNFS2023-10-04
06970163081229Opera System®Shining 3D Tech Co., Ltd.NFS2023-08-23
B915015700521zebris for ceramill USB-Lzebris MEDICAL GmbHNFS2023-07-24
B915011700230Tizian JMA Optic USBzebris MEDICAL GmbHNFS2023-07-20
B915011700410ARCUSdigma 3 USBzebris MEDICAL GmbHNFS2023-07-20
B915011700510zebris for ceramill USBzebris MEDICAL GmbHNFS2023-07-20
B915011700720PlaneAnalyser II USBzebris MEDICAL GmbHNFS2023-07-20
B915015700131JMA Optic USB-Lzebris MEDICAL GmbHNFS2023-07-20
B915015700231Tizian JMA Optic USBzebris MEDICAL GmbHNFS2023-07-20
B915015700411ARCUSdigma 3 USBzebris MEDICAL GmbHNFS2023-07-20
B915015700511zebris for ceramill USBzebris MEDICAL GmbHNFS2023-07-20
B915015700721PlaneAnalyser II USBzebris MEDICAL GmbHNFS2023-07-20
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
B915019604000Bite Fork Adapter / Fusion Bite Adapterzebris MEDICAL GmbHNFS2023-07-13