Definition: For The Fabrication Of Long-term Temporary Crowns And Bridges
| Device Type ID | 1387 |
| Device Name | Crown And Bridge, Long-term Temporary, Resin |
| Physical State | Polymeric, May Include Ceramic Filler |
| Technical Method | Achieves Its Intended Function By Providing A Patient-matched Crown Or Bridge That Is Cemented Onto A Patient's Dentition To Restore Normal Mastication |
| Target Area | Oral Cavity |
| Regulation Description | Temporary Crown And Bridge Resin. |
| Regulation Medical Specialty | Dental |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.3770 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | POW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1387 |
| Device | Crown And Bridge, Long-term Temporary, Resin |
| Product Code | POW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Temporary Crown And Bridge Resin. |
| CFR Regulation Number | 872.3770 [🔎] |