Definition: Intended To Improve An Individual's Appearance Only. Not Intended To Assist In Chewing Food.
Device Type ID | 1419 |
Device Name | Denture, Cosmetic Only |
Physical State | Denture Rebasing Resin, Methylmethacrylate |
Technical Method | Functions Independently |
Target Area | Oral Cavity |
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 | Enforcement Discretion |
FDA Device Classification | Class Not Classified Medical Device |
Product Code | NXJ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1419 |
Device | Denture, Cosmetic Only |
Product Code | NXJ |