Device Type ID | 1159 |
Device Name | Wax, Dental, Intraoral |
Regulation Description | Intraoral Dental Wax. |
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 | 872.6890 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | EGD |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1159 |
Device | Wax, Dental, Intraoral |
Product Code | EGD |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Intraoral Dental Wax. |
CFR Regulation Number | 872.6890 [🔎] |