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(a) Jaw tracking device for monitoring mandibular jaw positions relative to the maxilla - (1) Identification. A jaw tracking device for monitoring mandibular jaw positions relative to the maxilla is a nonpowered or electrically powered device that measures and records anatomical distances and angles in three dimensional space, to determine the relative position of the mandible with respect to the location and position of the maxilla, while at rest and during jaw movement.
(2) Classification. Class I (general controls). The device is exempt from the premarket notification provisions of subpart E of part 807 of this chapter subject to § 872.9.
(b) Jaw tracking device for interpretation of mandibular jaw positions for the diagnosis - (1) Identification. A jaw tracking device for interpretation of mandibular jaw positions relative to the maxilla for the diagnosis of temporomandibular joint disorders and associated orofacial pain is a nonpowered or electrically powered device that measures and records anatomical distances and angles to determine the relative position of the mandible in three dimensional space, with respect to the location and position of the maxilla, while at rest and during jaw movement. The device records, displays, and stores information about jaw position. The device interprets jaw position to generate meaningful output, either directly or by connection to a personal computer. The device may be a part of a system of devices, contributing jaw position 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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