NFQ · Device, Dental Sonography, For Monitoring Jaw Sounds
Dental · 21 CFR 872.2050 · Class 1
Overview
| Product Code | NFQ |
|---|---|
| Device Name | Device, Dental Sonography, For Monitoring Jaw Sounds |
| Regulation | 21 CFR 872.2050 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A dental sonography device for interpretation and diagnosis is an electrically powered device, intended to interpret temporomandibular joint sounds for the diagnosis of temporomandibular joint disorders and associated orofacial pain. The device detects, records, displays, and stores sounds made by the temporomandibular joint during jaw movement. The device interprets these sounds to generate meaningful output, either directly or by connection to a personal computer. The device may be part of a system of devices, contributing joint sound information to be considered with data from other diagnostic components.
Classification Rationale
Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices.”
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices.”
Cleared Devices (4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K970116 | ESG-1 ELECTROSONOGRAM (ESG-1) | Myo-Tronics, Inc. | Apr 2, 1997 | SESE |
| K905657 | SONOPAK/QS, SONOPAK | Bioresearch | May 15, 1991 | SESE |
| K905449 | ELECTROSONOGRAM ESG-1 | Myo-Tronics, Inc. | Apr 26, 1991 | SESE |
| K862286 | ARTHROPHONOMETER | Arthrotek, Inc. | Jan 7, 1987 | SESE |
Top Applicants
- Myo-Tronics, Inc. — 2 clearances
- Bioresearch — 1 clearance
- Arthrotek, Inc. — 1 clearance
