The following data is part of a premarket notification filed by Sterngold/implamed with the FDA for Stern Era Implant Abutment.
| Device ID | K914764 |
| 510k Number | K914764 |
| Device Name: | STERN ERA IMPLANT ABUTMENT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STERNGOLD/IMPLAMED C/O MEDICAL DEVICE CONULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Contact | Lynne Aronson |
| Correspondent | Lynne Aronson STERNGOLD/IMPLAMED C/O MEDICAL DEVICE CONULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-22 |
| Decision Date | 1992-01-17 |