Jt-3d

FDA UDI

Class I (US FDA UDI)

by Bio-Research Associates, Inc.

Identity

Trade Name: JT-3D FDA UDI
Generic Name: Jaw physiology evaluation system FDA UDI
Device Name: 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.” FDA UDI
Model / Reference: NR 16 Channel FDA UDI
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.” FDA UDI

Identifiers

Primary DI / UDI-DI: 00860003499917 FDA UDI
510(k) Number: K952218 FDA UDI
FDA Product Code: NFS FDA UDI
GMDN Term: Jaw physiology evaluation system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.2060 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Jaw physiology evaluation system

Jt-3d by Bio-Research Associates, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Bio-Research Associates, Inc.

Sources (1)

FDA UDI 75f9a34c-a16e-4a7f-8f72-c79ae1ed7bd8 35 fields · synced Jun 6, 2026