Winsix Implant System: Flat Shift System
The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). ABUTMENTS are used…
The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). ABUTMENTS are used for creation of screwed temporary or fixed elements. They have different features to allow the physician to adapt to the different anatomical situation. Cover screws are used for the restorative phase after implantation.
15manufacturers in China registered for this device type
41catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (11), Jiangsu (2), Shanghai (1). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Modern Dental Laboratory (DG) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 15 |
| Exceldent Dental Technology Development Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 12 |
| DTS Digital Dental LAB | Shenzhen | Guangdong | Contract manufacturer | 11 |
| KTJ Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Shimmer Computerized Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 10 |
| Zhuhai Crystal Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 9 |
| NEW Perfect Dental LAB | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen Jiahong Dental Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| CBD Dental LAB, Inc | Shenzhen | Guangdong | Manufacturer | 11 |
Showing 12 of 15. All 15 manufacturers in China registered for Abutment, Implant, Dental, Endosseous
Record
| Listed by | Biosaf IN SRL |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| 510(k) | K133733 |
| Record published | 2016-09-20 |
| Record revised | 2018-07-06 (version 3) |
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 |
| Sizes | Outer diameter 3.3 to 5.2 mm; height 1 to 5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Flat Shift Prostehetic Screw | In distribution | |
| Temporary Direct Counterbore Flat Shift Abutment Ø 5.2 GH 1mm | Height 1 mm | In distribution |
| Temporary Direct Counterbore Flat Shift Abutment Ø 3.8 GH 2mm | Height 2 mm | In distribution |
| Flat Shift Abutment Ø 5.2 GH 5mm for internal hex connection | Height 5 mm | In distribution |
| Cylindrical Direct Flat Shift Abutment Ø 4.5 GH 3mm | Height 3 mm | In distribution |
| Temporary Direct Counterbore Flat Shift Abutment Ø 3.3 GH 3mm | Height 3 mm | In distribution |
| Cylindrical Direct Flat Shift Abutment Ø 3.8 GH 2mm | Height 2 mm | In distribution |
| Cylindrical Direct Flat Shift Abutment Ø 3.3 GH 2mm | Height 2 mm | In distribution |
| Flat Shift Abutment Ø 5.2 GH 3mm for internal hex connection | Height 3 mm | In distribution |
| Cylindrical Direct Flat Shift Abutment Ø 4.5 GH 1mm | Height 1 mm | In distribution |
| Cylindrical Direct Flat Shift Abutment Ø 5.2 GH 3mm | Height 3 mm | In distribution |
| Flat Shift Abutment Ø 5.2 GH 4mm for internal hex connection | Height 4 mm | In distribution |
| Flat Shift Abutment Ø 4.5 GH 4mm for internal hex connection | Height 4 mm | In distribution |
| Temporary Direct Counterbore Flat Shift Abutment Ø 4.5 GH 2mm | Height 2 mm | In distribution |
| Flat Shift Cover Screw Ø 5.2 | Outer Diameter 5.2 mm | In distribution |
| Flat Shift Abutment Ø 3.3 GH 4mm for internal hex connection | Height 4 mm | In distribution |
| Cylindrical Direct Flat Shift Abutment Ø 3.8 GH 3mm | Height 3 mm | In distribution |
| Flat Shift Abutment Ø 3.8 GH 4mm for internal hex connection | Height 4 mm | In distribution |
| Temporary Direct Counterbore Flat Shift Abutment Ø 3.8 GH 3mm | Height 3 mm | In distribution |
| Flat Shift Cover Screw Ø 3.8 | Outer Diameter 3.8 mm | In distribution |
| Cylindrical Direct Flat Shift Abutment Ø 3.3 GH 1mm | Height 1 mm | In distribution |
| Cylindrical Direct Flat Shift Abutment Ø 4.5 GH 2mm | Height 2 mm | In distribution |
| Cylindrical Direct Flat Shift Abutment Ø 3.8 GH 1mm | Height 1 mm | In distribution |
| Temporary Direct Counterbore Flat Shift Abutment Ø 4.5 GH 1mm | Height 1 mm | In distribution |
| Temporary Direct Counterbore Flat Shift Abutment Ø 5.2 GH 3mm | Height 3 mm | In distribution |
| Flat Shift Abutment Ø 4.5 GH 3mm for internal hex connection | Height 3 mm | In distribution |
| Flat Shift Cover Screw Ø 4.5 | Outer Diameter 4.5 mm | In distribution |
| Cylindrical Direct Flat Shift Abutment Ø 3.3 GH 3mm | Height 3 mm | In distribution |
| Temporary Direct Counterbore Flat Shift Abutment Ø 3.8 GH 1mm | Height 1 mm | In distribution |
| Flat Shift Abutment Ø 3.3 GH 3mm for internal hex connection | Height 3 mm | In distribution |
| Flat Shift Cover Screw Ø 3.3 | Outer Diameter 3.3 mm | In distribution |
| Cylindrical Direct Flat Shift Abutment Ø 5.2 GH 2mm | Height 2 mm | In distribution |
| Flat Shift Abutment Ø 3.8 GH 5mm for internal hex connection | Height 5 mm | In distribution |
| Temporary Direct Counterbore Flat Shift Abutment Ø 4.5 GH 3mm | Height 3 mm | In distribution |
| Flat Shift Abutment Ø 4.5 GH 5mm for internal hex connection | Height 5 mm | In distribution |
| Flat Shift Abutment Ø 3.3 GH 5mm for internal hex connection | Height 5 mm | In distribution |
| Temporary Direct Counterbore Flat Shift Abutment Ø 3.3 GH 1mm | Height 1 mm | In distribution |
| Cylindrical Direct Flat Shift Abutment Ø 5.2 GH 1mm | Height 1 mm | In distribution |
| Temporary Direct Counterbore Flat Shift Abutment Ø 5.2 GH 2mm | Height 2 mm | In distribution |
| Temporary Direct Counterbore Flat Shift Abutment Ø 3.3 GH 2mm | Height 2 mm | In distribution |
| Flat Shift Abutment Ø 3.8 GH 3mm for internal hex connection | Height 3 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MEDENTiKA | Medentika GmbH | 2,553 |
| LW Vis Abutment | Ossvis Co., Ltd. | 2,520 |
| Dess dental smart solutions | Terrats Medical SL | 1,715 |
| Locator | Zest Anchors, LLC | 1,643 |
| NobelProcera® | Nobel Biocare AB | 1,526 |
| Azure | Terrats Medical SL | 1,360 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 1,308 |
| LW Vis Abutment SET | Ossvis Co., Ltd. | 1,260 |
| Abutment, Implant, Dental, Endosseous | Southern Implants (PTY) Ltd | 1,240 |
| Healing Abutment | Megagen Implant Co., Ltd. | 1,218 |
| Chaorum Implant System | Medimecca Co Ltd | 1,084 |
| OT Equator | Rhein 83 SRL | 1,051 |
Showing 12 of 6,204. All products under Abutment, Implant, Dental, Endosseous
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.