The following data is part of a premarket notification filed by Sterngold with the FDA for Sterngold Acid Etch Dental Implant System.
| Device ID | K023580 |
| 510k Number | K023580 |
| Device Name: | STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STERNGOLD 5 WHITCOMB AVE. Ayer, MA 01432 |
| Contact | Pamela Papineau |
| Correspondent | Pamela Papineau STERNGOLD 5 WHITCOMB AVE. Ayer, MA 01432 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-24 |
| Decision Date | 2003-01-17 |
| Summary: | summary |