Device Type ID | 1317 |
Device Name | Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile |
Regulation Description | Manual Toothbrush. |
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 | 872.6855 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | MCF |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1317 |
Device | Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile |
Product Code | MCF |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Manual Toothbrush. |
CFR Regulation Number | 872.6855 [🔎] |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Ceg Enterprises Llc | II | Jun-23-2016 |