| Device Type ID | 1226 |
| Device Name | Point, Paper, Endodontic |
| Regulation Description | Endodontic Paper Point. |
| 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 | 872.3830 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EKN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1226 |
| Device | Point, Paper, Endodontic |
| Product Code | EKN |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Endodontic Paper Point. |
| CFR Regulation Number | 872.3830 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ultradent Products, Inc. | II | Sep-26-2017 |