The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for The Maestro System.
| Device ID | K010458 |
| 510k Number | K010458 |
| Device Name: | THE MAESTRO SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH Birmingham, AL 35243 |
| Contact | Steven Boggan |
| Correspondent | Steven Boggan BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH Birmingham, AL 35243 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-16 |
| Decision Date | 2001-05-10 |