The following data is part of a premarket notification filed by Bicon, Llc with the FDA for Bicon Dental Implant System 3.0mm Bicon Dental Implant.
| Device ID | K101849 |
| 510k Number | K101849 |
| Device Name: | BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BICON, LLC 501 ARBORWAY Boston, MA 02130 |
| Contact | Vincent Morgan, D.m.d. |
| Correspondent | Vincent Morgan, D.m.d. 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 | 2010-07-01 |
| Decision Date | 2010-10-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813110027429 | K101849 | 000 |
| 00813110022493 | K101849 | 000 |
| 00813110022486 | K101849 | 000 |
| 00813110020635 | K101849 | 000 |