Den-Mat Dentin Bonding Agent
by Den-Mat Corp. 510(k)
Active
510(k) K801216
Overview
The DEN-MAT DENTIN BONDING AGENT is a widely recognized and respected dental device used in the bonding of dentures to ensure optimal fit, comfort, and functionality. With its proven track record of reliability and efficacy, this agent has become an industry standard for professionals seeking high-quality solutions for their patients.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801216 | Date28 May 1980 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KLE
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3200
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent