The following data is part of a premarket notification filed by Bicon, Inc. with the FDA for 6.0 X 5.7mm Dental Implant.
| Device ID | K010185 |
| 510k Number | K010185 |
| Device Name: | 6.0 X 5.7MM DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BICON, INC. 123 MORTON ST., 2ND FL. Boston, MA 02130 |
| Contact | Vincent J Morgan |
| Correspondent | Vincent J Morgan BICON, INC. 123 MORTON ST., 2ND FL. 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 | 2001-01-19 |
| Decision Date | 2002-12-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813110023070 | K010185 | 000 |
| 00813110023063 | K010185 | 000 |
| 00813110021212 | K010185 | 000 |
| 00813110021205 | K010185 | 000 |