K7 ESG-2 Electrosonograph

Primary DI
D79209830
Brand
K7 ESG-2 Electrosonograph
Company
MYOTRONICS NOROMED, INC
Model
ESG-2
Catalog number
0983
Device 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.
Published
2016-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NFQDevice, Dental Sonography, For Monitoring Jaw Sounds

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NFQDevice, Dental Sonography, For Monitoring Jaw SoundsDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970116000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970116000ESG-1 ELECTROSONOGRAM (ESG-1)Myo-Tronics, Inc.1997-04-02NFQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D79209830PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
053824652
Device count
1
Serial number
true
Manufacturing date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860003499924BioJVABio-Research Associates, Inc.NFQ2023-06-22
00860003499931BioJVABio-Research Associates, Inc.NFQ2023-06-22
00860009598218BioJVABio-Research Associates, Inc.NFQ2023-06-22
D79209750K7 Evaluation System-ESGMYOTRONICS NOROMED, INCNFQ2016-09-19