Subpart F—Therapeutic Devices
FDA submissions for Subpart F—Therapeutic Devices in the Dental (DE) review panel, including product codes and regulations.
Section range: §§ 872.5410–872.5580
CFR Part: 872
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| DYJ | Retainer, Screw Expansion, Orthodontic | 872.5410 | 1 | 5 |
| DYO | Band, Material, Orthodontic | 872.5410 | 1 | 3 |
| DZC | Wire, Orthodontic | 872.5410 | 1 | 30 |
| DZD | Tube, Orthodontic | 872.5410 | 1 | 8 |
| ECI | Band, Elastic, Orthodontic | 872.5410 | 1 | 25 |
| ECM | Band, Preformed, Orthodontic | 872.5410 | 1 | 2 |
| ECN | Clamp, Wire, Orthodontic | 872.5410 | 1 | 0 |
| ECO | Spring, Orthodontic | 872.5410 | 1 | 7 |
| EJF | Bracket, Metal, Orthodontic | 872.5410 | 1 | 103 |
| NQS | Bracket, Metal, Orthodontic, Reprocessed | 872.5410 | 1 | 0 |
| QJJ | Indirect Bonding Tray | 872.5410 | 1 | 0 |
| DYW | Bracket, Plastic, Orthodontic | 872.5470 | 2 | 42 |
| NJM | Bracket, Ceramic, Orthodontic | 872.5470 | 2 | 60 |
| NLC | Bracket, Plastic, Orthodontic, Reprocessed | 872.5470 | 2 | 0 |
| NXC | Aligner, Sequential | 872.5470 | 2 | 143 |
| OYH | Orthodontic Vibratory Accessory | 872.5470 | 2 | 5 |
| PLH | Orthodontic Led Accessory | 872.5470 | 2 | 2 |
| PNN | Orthodontic Software | 872.5470 | 2 | 33 |
| DZB | Headgear, Extraoral, Orthodontic | 872.5500 | 2 | 36 |
| DYT | Maintainer, Space Preformed, Orthodontic | 872.5525 | 1 | 4 |
| KMY | Positioner, Tooth, Preformed | 872.5525 | 1 | 12 |
| KKO | Ring, Teething, Fluid-Filled | 872.5550 | 2 | 27 |
| MEF | Ring, Teething, Non-Fluid Filled | 872.5550 | 1 | 1 |
| LTF | Stimulator, Salivary System | 872.5560 | 2 | 3 |
| QTT | Over The Counter Electrical Salivary Stimulatory System | 872.5560 | 2 | 2 |
| LQZ | Device, Jaw Repositioning | 872.5570 | 2 | 27 |
| LRK | Device, Anti-Snoring | 872.5570 | 2 | 210 |
| MYB | Pillow, Cervical (For Mild Sleep Apnea) | 872.5570 | 2 | 6 |
| OHP | Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea | 872.5570 | 2 | 5 |
| ORY | Tongue Suspension System | 872.5570 | 2 | 10 |
| OZR | Intraoral Pressure Gradient Device | 872.5570 | 2 | 6 |
| PLC | Sleep Appliances With Patient Monitoring | 872.5570 | 2 | 9 |
| QCJ | Closed Loop Auto Titration Device For Oral Appliances | 872.5571 | 2 | 1 |
| QNO | Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea | 872.5575 | 2 | 3 |
| NTO | Rinse, Oral, Antibacterial (By Physical Means) | 872.5580 | 2 | 2 |
