The following data is part of a premarket notification filed by Sterngold/implamed with the FDA for The Stern Root Anchor System.
| Device ID | K950213 |
| 510k Number | K950213 |
| Device Name: | THE STERN ROOT ANCHOR SYSTEM |
| Classification | Post, Root Canal |
| Applicant | STERNGOLD/IMPLAMED 13794 N.W. 4TH ST., SUITE 209 Sunrise, FL 33325 |
| Contact | Nicholas Savarese |
| Correspondent | Nicholas Savarese STERNGOLD/IMPLAMED 13794 N.W. 4TH ST., SUITE 209 Sunrise, FL 33325 |
| Product Code | ELR |
| CFR Regulation Number | 872.3810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-19 |
| Decision Date | 1995-03-23 |