PROFLEX FLEXIBLE SCALER
Device Facts
| Record ID | K821364 |
|---|---|
| Device Name | PROFLEX FLEXIBLE SCALER |
| Applicant | Teledyne Densco |
| Product Code | EHM · Dental |
| Decision Date | May 28, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.6010 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An abrasive device and accessories is a device constructed of various abrasives, such as diamond chips, that are glued to shellac-based paper. The device is intended to remove excessive restorative materials, such as gold, and to smooth rough surfaces from oral restorations, such as crowns. The device is attached to a shank that is held by a handpiece. The device includes the abrasive disk, guard for an abrasive disk, abrasive point, polishing agent strip, and polishing wheel.
