21 CFR § 872.2050 - Dental sonography device.

§ 872.2050 Dental sonography device.

(a) Dental sonography device for monitoring -

(1) Identification. A dental sonography device for monitoring is an electrically powered device, intended to be used to monitor temporomandibular joint sounds. The device detects and records sounds made by the temporomandibular joint.

(2) Classification. Class I. The device is exempt from the premarket notification provisions of subpart E of part 807 of this chapter subject to § 872.9.

(b) Dental sonography device for interpretation and diagnosis -

(1) 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.

(2) 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.”

[68 FR 67367, Dec. 2, 2003]

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