HexaPLUS S OneDrill Implant System
The HexaPLUS S OneDrill Implant System supports tooth replacements in partially or completely edentulous upper or lower jaws. It can support single or multiple unit cement retained or screw…
The HexaPLUS S OneDrill Implant System supports tooth replacements in partially or completely edentulous upper or lower jaws. It can support single or multiple unit cement retained or screw retained restorations, overdentures and fixed bridgework.
Titanium alloy fixtures are surgically placed in the jawbone and have an SLA treated surface. The system includes abutments that connect the implanted fixtures to the planned restoration, together with cover and abutment screws.
Surgical Scope
The implant system is intended for one or two stage surgery with delayed loading. Fixture body diameters range from 4.5 to 7.5 mm, with several lengths available to accommodate the selected restoration and bone anatomy.
Who Else Makes It
Concentrated in Jiangsu (3), Sichuan (2), Shanghai (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Basic (Chengdu) Medical Device Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 1 |
| Dongguan Xinlonghong Hardware Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 1 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| BIO Concept Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | Osseofuse International Inc., United States |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K243078 |
| Record published | 2025-11-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HSF7510 | In distribution | |
| HSF7516 | In distribution | |
| HSF6511 | In distribution | |
| HSF7513 | In distribution | |
| HSF4510 | In distribution | |
| HSF4511 | In distribution | |
| HSF5208 | In distribution | |
| HSF7511 | In distribution | |
| HSF6508 | In distribution | |
| HSF7514 | In distribution | |
| HSF4508 | In distribution | |
| HSF4513 | In distribution | |
| HSF4514 | In distribution | |
| HSF5210 | In distribution | |
| HSF5216 | In distribution | |
| HSF6513 | In distribution | |
| HSF4516 | In distribution | |
| HSF6516 | In distribution | |
| HSF7508 | In distribution | |
| HSF5213 | In distribution | |
| HSF5214 | In distribution | |
| HSF6510 | In distribution | |
| HSF5211 | In distribution | |
| HSF6514 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 920 |
| Osstem Implant System | Osstem Implant Co., Ltd. | 788 |
| Magicore | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 744 |
| Implant, Endosseous, Root-Form | Southern Implants (PTY) Ltd | 608 |
| ITL Dental | Emery Enterprises Inc. | 603 |
| Magicore S | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 560 |
| Friadent® | Dentsply Implants Manufacturing GmbH | 525 |
| Sphero Block Normo | Rhein 83 SRL | 489 |
| Neobiotech Implant System | Neobiotech Co., Ltd. | 483 |
| KJ Mini Implant System | Kjmeditech.co., Ltd. | 448 |
| Ritter Dental Implant System | Ritter Implants GmbH & Co. KG | 418 |
| Leone SPA | Leone SPA | 404 |
Showing 12 of 2,762. All products under Implant, Endosseous, Root-Form
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243078 | 2025-10-10 |
| K181157 | 2019-05-24 |
| K133050 | 2014-09-19 |
| K131748 | 2013-10-31 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P800035 | 2001-10-04 | PERI-OSS | Curasan AG |
| P860012 | 1988-10-28 | ALVEOFORM TM BIOGRAFT | Collagen Corp. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.