Diagnostic devices · 21 CFR 872 Subpart B

Dental Sonography Device for Monitoring Jaw Sounds

FDA device type “Device, Dental Sonography, For Monitoring Jaw Sounds”.

FDA codeNFQClass121 CFR872.2050Pathway510(k) exempt
Companies listing it
54 makers
Brands and models
7
510(k) clearances
40 in five years
FDA name
Device, Dental Sonography, For Monitoring Jaw Sounds
1987: 11991: 21997: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list NFQ

5 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
BioresearchUnited StatesMakerBioJVA · BioJVA Wireless · BioPAK21995
Great Lakes Dental Technologies, Ltd.United StatesMakerGreat Lakes Ortho Doppler——
Weldon InstrumentsPakistanMakerNFQ / Device, dental sonography, for monitoring jaw sounds——
Myotronics-Noromed, IncUnited StatesMakerESG-1 ELECTROSONOGRAM——
Dentimed Sao Joao LLCUnited StatesRepacker / relabelerDENTQ——

510(k) clearances

Decided510(k)DeviceApplicant
2 Apr 1997K970116ESG-1 ELECTROSONOGRAM (ESG-1)Myo-Tronics, Inc.
15 May 1991K905657SONOPAK/QS, SONOPAKBioresearch
26 Apr 1991K905449ELECTROSONOGRAM ESG-1Myo-Tronics, Inc.
7 Jan 1987K862286ARTHROPHONOMETERArthrotek, Inc.

Official records: FDA product classification for NFQ · 21 CFR 872.2050.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026