Device Type ID | 1227 |
Device Name | Denture Preformed (partially Prefabricated Denture) |
Regulation Description | Partially Fabricated Denture Kit. |
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 | 872.3600 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | EKO |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |