The following data is part of a premarket notification filed by Bicon, Inc. with the FDA for The 6.0 X 8.0mm Dental Implant System.
| Device ID | K972417 |
| 510k Number | K972417 |
| Device Name: | THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BICON, INC. 1153 CENTRE ST., SUITE 21 Boston, MA 02130 |
| Contact | Vincent J Morgan |
| Correspondent | Vincent J Morgan BICON, INC. 1153 CENTRE ST., SUITE 21 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 | 1997-06-27 |
| Decision Date | 1997-09-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813110023049 | K972417 | 000 |