The following data is part of a premarket notification filed by Bicon, Inc. with the FDA for The 4.5mm Diameter Bicon Dental Implant.
| Device ID | K994037 |
| 510k Number | K994037 |
| Device Name: | THE 4.5MM DIAMETER BICON DENTAL IMPLANT |
| 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 | 1999-11-29 |
| Decision Date | 2000-01-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813110022707 | K994037 | 000 |
| 00813110022691 | K994037 | 000 |
| 00813110020956 | K994037 | 000 |
| 00813110020949 | K994037 | 000 |
| 00813110020925 | K994037 | 000 |