KOP · Adhesive, Denture, Karaya
Dental · 21 CFR 872.3450 · Class 1
Overview
| Product Code | KOP |
|---|---|
| Device Name | Adhesive, Denture, Karaya |
| Regulation | 21 CFR 872.3450 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
Ethylene oxide homopolymer and/or karaya denture adhesive is a device composed of ethylene oxide homopolymer and/or karaya 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 if the device is made of wax-impregnated cotton cloth that the patient applies to the base or inner surface of a denture before inserting the denture into the mouth. The device is intended to be discarded following 1 day's use. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K802285 | OHIO THORACIC SUCTION REGULATOR | Ohio Medical Products | Oct 3, 1980 | SESE |
Top Applicants
- Ohio Medical Products — 1 clearance
