KOL · Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer
Dental · 21 CFR 872.3410 · Class 1
Overview
| Product Code | KOL |
|---|---|
| Device Name | Adhesive, Denture, Carboxymethylcellulose Sodium (32%) 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K884999 | HOLD-FAST DENTURE ADHESIVE | Iodent, Co. | Feb 24, 1989 | SESE |
| K791576 | FORGET - DENTURE BONDING LIQUID | Norcliff Thayer, Inc. | Oct 26, 1979 | SESE |
Top Applicants
- Norcliff Thayer, Inc. — 1 clearance
- Iodent, Co. — 1 clearance
