The following data is part of a premarket notification filed by Bicon, Inc. with the FDA for Bicon Transitional Implant (bti) System.
| Device ID | K023705 |
| 510k Number | K023705 |
| Device Name: | BICON TRANSITIONAL IMPLANT (BTI) SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BICON, INC. 501 ARBOWAY Boston, MA 02130 |
| Contact | Vincent J Morgan |
| Correspondent | Vincent J Morgan BICON, INC. 501 ARBOWAY 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 | 2002-11-04 |
| Decision Date | 2003-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813110023384 | K023705 | 000 |
| 00813110023360 | K023705 | 000 |