21 CFR 872.3500 — Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3500
Identification
Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive is a device composed of polyvinylmethylether maleic anhydride, acid copolymer, and carboxymethylcellulose sodium intended to be applied to the base of a denture before the denture is inserted in a patient's mouth to improve denture retention and comfort.
Classification Rationale
Class III.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KXY | Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce | 3 | 0 |