The following data is part of a premarket notification filed by Bicon, Inc. with the FDA for 4.5.* 6.0mm Dental Implant And 6.0*6.0 Mm Dental Implant.
| Device ID | K050712 |
| 510k Number | K050712 |
| Device Name: | 4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BICON, INC. 501 ARBORWAY Boston, MA 02130 |
| Contact | Vincent J Morgan |
| Correspondent | Vincent J Morgan BICON, INC. 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 | 2005-03-17 |
| Decision Date | 2005-04-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813110027856 | K050712 | 000 |
| 00813110027566 | K050712 | 000 |
| 00813110022684 | K050712 | 000 |
| 00813110020932 | K050712 | 000 |