Definition: Call For PMAs 12/26/96 Per 61 FR 50707 On 9/27/96
Device Type ID | 1303 |
Device Name | Polyvinyl Methylether Maleic Anhydride &/or Acid Copolymer & Carboxymethylce |
Regulation Description | Polyvinylmethylether Maleic Anhydride (PVM-MA), Acid Copolymer, And Carboxymethylcellulose Sodium (NACMC) Denture Adhesive. |
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 | PMA |
CFR Regulation Number | 872.3500 [🔎] |
FDA Device Classification | Class 3 Medical Device |
Product Code | KXY |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
|
Device Type ID | 1303 |
Device | Polyvinyl Methylether Maleic Anhydride &/or Acid Copolymer & Carboxymethylce |
Product Code | KXY |
FDA Device Classification | Class 3 Medical Device |
Regulation Description | Polyvinylmethylether Maleic Anhydride (PVM-MA), Acid Copolymer, And Carboxymethylcellulose Sodium (NACMC) Denture Adhesive. |
CFR Regulation Number | 872.3500 [🔎] |