The following data is part of a premarket notification filed by Pentron Corp. with the FDA for Pentra-fil Ii.
| Device ID | K840727 |
| 510k Number | K840727 |
| Device Name: | PENTRA-FIL II |
| Classification | Material, Tooth Shade, Resin |
| Applicant | PENTRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-21 |
| Decision Date | 1984-04-13 |