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- Subpart B—Diagnostic DevicesCFR Sub-Part
- EASGel, Electrode, For Pulp Tester1Product Code
- EATTester, Pulp2Product Code
- EGZHolder, Film, X-Ray1Product Code
- EHAAligner, Beam, X-Ray1Product Code
- JEOMeasurer, Gingival Fluid1Product Code
- LFCDevice, Caries Detection2Product Code
- MVHDevice, Detection, Sulfide2Product Code
- NBLLaser, Fluorescence Caries Detection2Product Code
- NFPDevice, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders2Product Code
- NFQDevice, Dental Sonography, For Monitoring Jaw Sounds1Product Code
- NFRDevice, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders2Product Code
- NFSDevice, Jaw Tracking, For Monitoring Jaw Positions1Product Code
- NTKCaries Detector, Laser Light, Transmission2Product Code
- NYHPlaque Disclosing Kit2Product Code
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- Subpart D—Prosthetic DevicesCFR Sub-Part
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- Subpart G—Miscellaneous DevicesCFR Sub-Part
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Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders
- Page Type
- Product Code
- Regulation Medical Specialty
- Dental
- Review Panel
- Dental
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 872.2050
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
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]