Definition: Air Compressor And Vacuum Unit That Are Connected To Dental Operative Unit To Provide Compressed Air And Vacuum Capability To Power And Drive Other Dental Devices, Which Are Attached To The Dental Operative Unit.
| Device Type ID | 1353 |
| Device Name | Unit, Operative Dental, Accessories |
| Regulation Description | Dental Operative Unit And Accessories. |
| 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) Exempt |
| CFR Regulation Number | 872.6640 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NRD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1353 |
| Device | Unit, Operative Dental, Accessories |
| Product Code | NRD |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Dental Operative Unit And Accessories. |
| CFR Regulation Number | 872.6640 [🔎] |