21 CFR 872.2050 — Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders
Dental (DE) · Subpart B—Diagnostic Devices · § 872.2050
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.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| NFP | Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders | 2 | 0 | |
| NFQ | Device, Dental Sonography, For Monitoring Jaw Sounds | 1 | 4 |
Special Controls
NFP — Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders
*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.”
eCFR
NFP — Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders
The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices.”
Ecfr Llm
NFQ — Device, Dental Sonography, For Monitoring Jaw Sounds
*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.”
eCFR
