Stoma® Titanium Bone Screw
STOMA® titanium bone screws Ø1,3 X 10mm are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures in the dental field. They are…
STOMA® titanium bone screws Ø1,3 X 10mm are developed and manufactured to be used as non-active bone surgery implants for the treatment of bone fractures in the dental field. They are recommended especially for the fixation of transplanted bone blocks during the augmentation process in the oral cavity and maxillomandibular surgical field. STOMA® titanium bone screws are delivered in non-sterile conditions.
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 | Storz AM Mark Gmbh, Germany |
|---|---|
| FDA product code | DZL |
| Device type | Screw, Fixation, Intraosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4880 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K051871 |
| Record published | 2015-10-17 |
| Record revised | 2025-06-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Outer diameter 1.3 to 2 mm; length 4 to 16 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 23053.10 | Outer Diameter 1.3 mm | 3 | In distribution |
| 23051.08 | Length 8 mm | 3 | In distribution |
| 23051.14 | Length 14 mm | 3 | In distribution |
| 23051.06 | Length 6 mm | 3 | In distribution |
| 23052.10 | Outer Diameter 2 mm | 3 | In distribution |
| 23052.14 | Outer Diameter 2 mm | 3 | In distribution |
| 23051.16 | Outer Diameter 1.6 mm | 3 | In distribution |
| 23051.10 | Length 10 mm | 3 | In distribution |
| 23052.12 | Outer Diameter 2 mm | 3 | In distribution |
| 23053.04 | Length 4 mm | 3 | In distribution |
| 23052.08 | Outer Diameter 2 mm | 3 | In distribution |
| 23053.08 | Length 8 mm | 3 | In distribution |
| 23052.16 | Outer Diameter 2 mm | 3 | In distribution |
| 23053.06 | Outer Diameter 1.3 mm | 3 | In distribution |
| 23051.12 | Length 12 mm | 3 | 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 |
|---|---|
| K080430 | 2008-11-21 |
| K051871 | 2005-10-27 |
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.