The following data is part of a premarket notification filed by Biohorizons Implant Systems, Inc. with the FDA for The Maestro System 3.0mm Diameter Implant.
| Device ID | K032351 |
| 510k Number | K032351 |
| Device Name: | THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOHORIZONS IMPLANT SYSTEMS, INC. ONE PERIMETER PARK SOUTH SUITE 230, SOUTH Birmingham, AL 35243 |
| Contact | Winston D Greer |
| Correspondent | Winston D Greer 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 | 2003-07-30 |
| Decision Date | 2003-10-21 |
| Summary: | summary |