Bone Screw, Bone Tack
Osstem Bone Screws and Bone Tacks stabilize graft-related materials during oral or maxillofacial reconstruction. The screws fix bone grafts, filling materials, plates or barrier membranes…
Osstem Bone Screws and Bone Tacks stabilize graft-related materials during oral or maxillofacial reconstruction. The screws fix bone grafts, filling materials, plates or barrier membranes used for bone regeneration. The tacks provide membrane fixation in guided bone regeneration.
Both are titanium alloy devices. Screw diameters are 1.4 or 1.95 mm, with size-dependent lengths from 4 to 16 mm. The tack has a 2.5 mm head and is 3 mm long. Their dimensions and fixation roles differ within the range.
Intended Reconstruction Use
The screw range maintains graft position in the oral cavity, while the tack indication includes grafts or fractured bone segments with or without bone plates or titanium mesh at oral and maxillofacial defects. Devices are supplied sterile for single use, with an eight-year shelf life stated for the screw range.
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Fujian (1). 2 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 |
| Dentalmaster (Xiamen) Medical Technology Co., Ltd. | Xiamen | Fujian | Manufacturer | 1 |
Record
| Listed by | Osstem Implant Co., Ltd., South Korea |
|---|---|
| FDA product code | DZL |
| Device type | Screw, Fixation, Intraosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4880 |
| Establishment | Contract manufacturer, Specification developer, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K182881 |
| Record published | 2026-03-09 |
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, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BSCH1408 | In distribution | |
| BSCH1406 | In distribution | |
| BSCH2012 | In distribution | |
| BSCH2014 | In distribution | |
| OBT3 | In distribution | |
| BSCH2016 | In distribution | |
| BSCH1404 | In distribution | |
| BSCH2010 | In distribution | |
| BSCH2008 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OsteoMed | Osteomed | 1,295 |
| Faico CMF System | Faico Medical, LLC | 540 |
| Neoface | Neoortho Produtos Ortopédicos S/A | 181 |
| CMF Visionare | Visionare LLC | 155 |
| Universal Mandible AXS | Stryker Leibinger Gmbh & Co. KG | 148 |
| Tandry CMF Plate System | Microware Precision Co., Ltd. | 140 |
| Screw, Fixation, Intraosseous | Synthes Gmbh | 132 |
| Level ONE CMF | KLS-Martin L.P. | 71 |
| MatrixMIDFACE | Synthes Gmbh | 65 |
| PlusDrive | Synthes Gmbh | 52 |
| Universal 2.0 MP AXS | Stryker Leibinger Gmbh & Co. KG | 51 |
| MCI – Medical Concept Innovation, Inc. | MCI Medical Concept Innovation Inc. | 49 |
Showing 12 of 92. All products under Screw, Fixation, Intraosseous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251569 | 2025-08-13 |
| K182881 | 2019-08-09 |
| K181854 | 2019-05-07 |
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.