KXW · Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer
Dental · 21 CFR 872.3410 · Class 1
Overview
| Product Code | KXW |
|---|---|
| Device Name | Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer |
| Regulation | 21 CFR 872.3410 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
An ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive is a device containing ethylene oxide homopolymer and/or 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 I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
