Osseofuse International, Inc. · Class II · Cleared Oct 10, 2025
| K-number | K243078 |
| Device name | HexaPLUS S OneDrill Implant System |
| Applicant | Osseofuse International, Inc. |
| Product code | DZE |
| Device class | Class II |
| Decision date | Oct 10, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 872.3640 |
The HexaPLUS S OneDrill Implant System is a dental implant system made of titanium alloy for surgical placement in the upper or lower jaw to support single or multiple-unit restorations, including cement-retained, screw-retained, or overdenture restorations. It is designed for one and two-stage surgical procedures with delayed loading in partially or fully edentulous patients.
The device features a bone-level implant with internal hexagon connection, straight-walled neck with microthread, and tapered body design. It uses titanium 6AL 4V ELI Gr.23 alloy with SLA surface treatment. Available in diameters of 4.5mm, 5.25mm, 6.5mm, and 7.5mm, and lengths of 8.5–16.0mm. The system includes various abutments (healing, one-step, cement, straight, angled, temporary, and ball), cover screws, and abutment screws.
Fatigue testing per ISO 14801 on angled abutments; Bacterial Endotoxins Test (BET) using kinetic Limulus Amebocyte Lysate (LAL) per USP <85>, USP <161>, and ANSI/AAMI ST72:2019; MRI assessment based on FDA guidance 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment' evaluating magnetically induced displacement force and torque.
The HexaPLUS S OneDrill is substantially equivalent to the predicate Conical Plus Implant System (K181157) because it has identical indications for use, identical design and mode of operation, and identical technological characteristics. Minor design changes in the fixture and ball abutments underwent performance testing confirming no safety or effectiveness concerns. Sterilization, shelf-life, and biocompatibility data are leveraged from the predicate device.
View the full FDA submission: accessdata.fda.gov