K020391 is an FDA 510(k) clearance for the STERN MICRO ERA ATTACHMENT SYSTEM. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Sterngold (Attleboro, US). The FDA issued a Cleared decision on March 8, 2002, 30 days after receiving the submission on February 6, 2002.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K020391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 2002 |
| Decision Date | March 08, 2002 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZE — Implant, Endosseous, Root-form |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3640 |