K243078 is an FDA 510(k) clearance for the HexaPLUS S OneDrill Implant System. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Osseofuse International, Inc. (Las Vegas, US). The FDA issued a Cleared decision on October 10, 2025, 375 days after receiving the submission on September 30, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K243078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2024 |
| Decision Date | October 10, 2025 |
| Days to Decision | 375 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZE - Implant, Endosseous, Root-form |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3640 |