Device Type ID | 1329 |
Device Name | Dental Cement W/out Zinc-oxide Eugenol As An Ulcer Covering For Pain Relief |
Regulation Description | Dental Cement. |
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) |
CFR Regulation Number | 872.3275 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | MZW |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |
Device Type ID | 1329 |
Device | Dental Cement W/out Zinc-oxide Eugenol As An Ulcer Covering For Pain Relief |
Product Code | MZW |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Dental Cement. |
CFR Regulation Number | 872.3275 [🔎] |