| Device Type ID | 1150 |
| Device Name | Amalgamator, Dental, Ac-powered |
| Regulation Description | Dental Amalgamator. |
| 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 | 872.3100 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EFD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1150 |
| Device | Amalgamator, Dental, Ac-powered |
| Product Code | EFD |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Dental Amalgamator. |
| CFR Regulation Number | 872.3100 [🔎] |
| Device Problems | |
|---|---|
Complete Blockage | 1 |
Device Issue | 1 |
Human Factors Issue | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Electronic Property Issue | 1 |
Infusion Or Flow Problem | 1 |
Use Of Device Problem | 1 |
Obstruction Of Flow | 1 |
| Total Device Problems | 8 |