| Device Type ID | 1231 |
| Device Name | File, Pulp Canal, Endodontic |
| Regulation Description | Dental Hand Instrument. |
| 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 | 872.4565 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EKS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1231 |
| Device | File, Pulp Canal, Endodontic |
| Product Code | EKS |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Dental Hand Instrument. |
| CFR Regulation Number | 872.4565 [🔎] |
| Device Problems | |
|---|---|
Break | 250 |
Material Separation | 10 |
Shaft | 8 |
Tip | 7 |
Use Of Device Problem | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Material Integrity Problem | 3 |
Material Discolored | 2 |
Compatibility Problem | 2 |
Fracture | 2 |
Device Handling Problem | 2 |
Material Deformation | 1 |
Detachment Of Device Or Device Component | 1 |
Packaging Problem | 1 |
Insufficient Information | 1 |
Device Operates Differently Than Expected | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 298 |