The following data is part of a premarket notification filed by Sterngold with the FDA for Sterngold 2.2mm Angles Micro Era Dental Implant System.
| Device ID | K092434 |
| 510k Number | K092434 |
| Device Name: | STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STERNGOLD 23 FRANK MOSSBERG DRIVE Attleboro, MA 02703 -0967 |
| Contact | Lee Clermont |
| Correspondent | Lee Clermont STERNGOLD 23 FRANK MOSSBERG DRIVE Attleboro, MA 02703 -0967 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-07 |
| Decision Date | 2009-11-10 |
| Summary: | summary |