The following data is part of a premarket notification filed by Zest Anchors, Inc. with the FDA for Zest Endodontic Stabilizer.
| Device ID | K801525 |
| 510k Number | K801525 |
| Device Name: | ZEST ENDODONTIC STABILIZER |
| Classification | Splint, Endodontic Stabilizing |
| Applicant | ZEST ANCHORS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELS |
| CFR Regulation Number | 872.3890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-01 |
| Decision Date | 1980-07-21 |