The following data is part of a premarket notification filed by Bicon, Llc with the FDA for 5.0 X 5.0mm Dental Implant And 6.0 X 5.0 Dental Implant.
| Device ID | K073368 |
| 510k Number | K073368 |
| Device Name: | 5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT |
| 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 | 2007-11-30 |
| Decision Date | 2008-10-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813110023056 | K073368 | 000 |
| 00813110022820 | K073368 | 000 |
| 00813110021199 | K073368 | 000 |
| 00813110021052 | K073368 | 000 |