The following data is part of a premarket notification filed by Teledyne Densco with the FDA for Proflex Flexible Scaler.
| Device ID | K821364 |
| 510k Number | K821364 |
| Device Name: | PROFLEX FLEXIBLE SCALER |
| Classification | Strip, Polishing Agent |
| Applicant | TELEDYNE DENSCO 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EHM |
| CFR Regulation Number | 872.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-07 |
| Decision Date | 1982-05-28 |