Subpart B—Diagnostic Devices
FDA submissions for Subpart B—Diagnostic Devices in the Dental (DE) review panel, including product codes and regulations.
Section range: §§ 872.1500–872.2060
CFR Part: 872
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| JEO | Measurer, Gingival Fluid | 872.1500 | 1 | 0 |
| EAT | Tester, Pulp | 872.1720 | 2 | 22 |
| EAS | Gel, Electrode, For Pulp Tester | 872.1730 | 1 | 0 |
| LFC | Device, Caries Detection | 872.1740 | 2 | 17 |
| NYH | Plaque Disclosing Kit | 872.1740 | 2 | 1 |
| NBL | Laser, Fluorescence Caries Detection | 872.1745 | 2 | 23 |
| NTK | Caries Detector, Laser Light, Transmission | 872.1745 | 2 | 11 |
| SBC | Dental Image Analyzer | 872.1770 | 2 | 1 |
| EHD | Unit, X-Ray, Extraoral With Timer | 872.1800 | 2 | 189 |
| MUH | System, X-Ray, Extraoral Source, Digital | 872.1800 | 2 | 206 |
| EAP | Unit, X-Ray, Intraoral | 872.1810 | 2 | 42 |
| EHA | Aligner, Beam, X-Ray | 872.1820 | 1 | 1 |
| EAG | Cephalometer | 872.1830 | 2 | 10 |
| EHB | Collimator, X-Ray | 872.1840 | 1 | 5 |
| EAH | Cone, Radiographic, Lead-Lined | 872.1850 | 1 | 2 |
| MVH | Device, Detection, Sulfide | 872.1870 | 2 | 1 |
| EGZ | Holder, Film, X-Ray | 872.1905 | 1 | 8 |
| NFP | Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders | 872.2050 | 2 | 0 |
| NFQ | Device, Dental Sonography, For Monitoring Jaw Sounds | 872.2050 | 1 | 4 |
| NFR | Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders | 872.2060 | 2 | 0 |
| NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 872.2060 | 1 | 2 |
