| Device Type ID | 1273 |
| Device Name | Floss, Dental |
| Regulation Description | Dental Floss. |
| 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 | 872.6390 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JES |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1273 |
| Device | Floss, Dental |
| Product Code | JES |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Dental Floss. |
| CFR Regulation Number | 872.6390 [🔎] |
| Device Problems | |
|---|---|
Break | 81 |
Adverse Event Without Identified Device Or Use Problem | 31 |
Detachment Of Device Component | 14 |
Detachment Of Device Or Device Component | 8 |
Appropriate Term/Code Not Available | 2 |
Cutter | 2 |
Battery Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Insufficient Information | 1 |
| Total Device Problems | 141 |