| Device Type ID | 1203 |
| Device Name | Bur, Dental |
| Regulation Description | Dental Bur. |
| 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 | 872.3240 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EJL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1203 |
| Device | Bur, Dental |
| Product Code | EJL |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Dental Bur. |
| CFR Regulation Number | 872.3240 [🔎] |
| Device Problems | |
|---|---|
Break | 31 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Material Integrity Problem | 2 |
Bent | 2 |
Detachment Of Device Or Device Component | 2 |
Insufficient Information | 1 |
No Audible Prompt / Feedback | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Positioning Failure | 1 |
Material Fragmentation | 1 |
Material Separation | 1 |
Material Twisted / Bent | 1 |
Use Of Device Problem | 1 |
| Total Device Problems | 50 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Coltene Whaledent Inc | II | May-14-2018 |