The following data is part of a premarket notification filed by Bicon, Llc with the FDA for Bicon Implants With A 2.5mm Internal Connection.
| Device ID | K092035 |
| 510k Number | K092035 |
| Device Name: | BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BICON, LLC 501 ARBORWAY Boston, MA 02130 |
| Contact | Vincent J Morgan |
| Correspondent | Vincent J Morgan BICON, LLC 501 ARBORWAY Boston, MA 02130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-06 |
| Decision Date | 2009-10-15 |