K7 Evaluation System-ESG

FDA UDI

Class II (US FDA UDI)

by Myotronics-Noromed, Inc.

Identity

Trade Name: K7 Evaluation System-ESG FDA UDI
Generic Name: Jaw physiology evaluation system FDA UDI
Device Name: TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sensitive vibration transducers over each TM joint, enabling simultaneous, bilateral capture of tissue vibrations emanating from joint sounds. Vibration (sound) data is correlated to vertical dimension of opening and closing, providing clinicians with valuable information to aid in assessing the status of articular disk and joint function. FDA UDI
Model / Reference: K7/ESG FDA UDI
Description: TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sensitive vibration transducers over each TM joint, enabling simultaneous, bilateral capture of tissue vibrations emanating from joint sounds. Vibration (sound) data is correlated to vertical dimension of opening and closing, providing clinicians with valuable information to aid in assessing the status of articular disk and joint function. FDA UDI

Identifiers

Primary DI / UDI-DI: D79209750 FDA UDI
FDA Product Code: KZM FDA UDI
IKN FDA UDI
NFS FDA UDI
NFQ FDA UDI
GMDN Term: Jaw physiology evaluation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.1375 FDA UDI
872.2060 FDA UDI
872.2050 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Jaw physiology evaluation system

K7 Evaluation System-ESG by Myotronics-Noromed, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Myotronics-Noromed, Inc.

Sources (1)

FDA UDI 016627f5-d957-44f7-9967-b435e4cb83dd 34 fields · synced May 30, 2026