| Device Type ID | 1225 |
| Device Name | Gutta-percha |
| Regulation Description | Gutta Percha. |
| 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 | 872.3850 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EKM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1225 |
| Device | Gutta-percha |
| Product Code | EKM |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Gutta Percha. |
| CFR Regulation Number | 872.3850 [🔎] |
| Device Problems | |
|---|---|
Overfill | 4 |
Inappropriate Shock | 2 |
Patient-Device Incompatibility | 1 |
Device Operates Differently Than Expected | 1 |
Incorrect Measurement | 1 |
Smoking | 1 |
Wire | 1 |
Circuit Failure | 1 |
Electrical /Electronic Property Problem | 1 |
Material Frayed | 1 |
Device Handling Problem | 1 |
| Total Device Problems | 15 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ormco/Sybronendo | II | Mar-08-2016 |