JT-3D

GUDID 00860003499917

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.”

Bio-Research Associates, Inc.

Jaw physiology evaluation system
Primary Device ID00860003499917
NIH Device Record Key75f9a34c-a16e-4a7f-8f72-c79ae1ed7bd8
Commercial Distribution StatusIn Commercial Distribution
Brand NameJT-3D
Version Model NumberNR 16 Channel
Company DUNS063501373
Company NameBio-Research Associates, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone4143577525
Emailinfo@bioresearchinc.com
Phone4143577525
Emailinfo@bioresearchinc.com
Phone4143577525
Emailinfo@bioresearchinc.com
Phone4143577525
Emailinfo@bioresearchinc.com
Phone4143577525
Emailinfo@bioresearchinc.com
Phone4143577525
Emailinfo@bioresearchinc.com
Phone4143577525
Emailinfo@bioresearchinc.com
Phone4143577525
Emailinfo@bioresearchinc.com
Phone4143577525
Emailinfo@bioresearchinc.com
Phone4143577525
Emailinfo@bioresearchinc.com
Phone4143577525
Emailinfo@bioresearchinc.com
Phone4143577525
Emailinfo@bioresearchinc.com
Phone4143577525
Emailinfo@bioresearchinc.com
Phone4143577525
Emailinfo@bioresearchinc.com
Phone4143577525
Emailinfo@bioresearchinc.com
Phone4143577525
Emailinfo@bioresearchinc.com
Phone4143577525
Emailinfo@bioresearchinc.com
Phone4143577525
Emailinfo@bioresearchinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860003499917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NFSDevice, Jaw Tracking, For Monitoring Jaw Positions

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-30
Device Publish Date2023-06-22

Devices Manufactured by Bio-Research Associates, Inc.

00860009598201 - Taylor Industries2023-08-25
00860003499900 - BioEMG2023-06-30 Indications for use: 8 channel EMG Amplifier 1. To record electrical activity of muscles of the stomatognathic system, especiall
00860003499917 - JT-3D2023-06-30The 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.”
00860003499917 - JT-3D2023-06-30 The Jaw Tracker-3D is a non-invasive, non-painful test that records incisor-point movements in three dimensions. A small magnet,
00860003499924 - BioJVA2023-06-30 Indications for use: 2 channel JVA amplifier 1. To record and display sounds/vibrations from the temporomandibular joints. 2. To
00860003499931 - BioJVA2023-06-30
00860003499948 - BioPAK2023-06-30
00860003499955 - M-Scan2023-06-30 M-Scan is specifically designed to record craniofacial muscle activity during function and resting.
00860003499962 - M-Scan2023-06-30 M-Scan is specifically designed to record craniofacial muscle activity during function and resting.

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