PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM
Device Facts
| Record ID | K050386 |
|---|---|
| Device Name | PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM |
| Applicant | Dentsply International |
| Product Code | KLE · Dental |
| Decision Date | Feb 23, 2005 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 872.3200 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.
