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 |