S-Clean Link Abutment
s-Clean Link Abutment supports customized dental crowns and bridges through a two-piece assembly. A stock titanium alloy link abutment connects to the implant by screw, and a…
s-Clean Link Abutment supports customized dental crowns and bridges through a two-piece assembly. A stock titanium alloy link abutment connects to the implant by screw, and a patient-specific zirconia coping is cemented onto the link.
The link and abutment screw use Ti-6Al-4V ELI alloy. The family includes Regular and Mini connections for corresponding Dentis s-Clean s-Line implants, with link diameters of 4.5 and 4.8 mm.
Listed Item
Dental Implant Abutment / s-Clean Link Abutment / DSLAMC453547HS
Customization and Sterilization
The zirconia coping is designed with CAD/CAM software and manufactured through the Dentis milling center within defined design limits. The assembly is supplied nonsterile and must be sterilized after the patient-specific superstructure has been cemented to the link abutment.
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 | Dentis Co., Ltd., South Korea |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K222913 |
| Record published | 2023-01-18 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DSLARC453047N | In distribution | |
| DSLAMC453547HS | In distribution | |
| DSLAM481045N | In distribution | |
| DSLARC451047NS | In distribution | |
| DSLAR482045H | In distribution | |
| DSLAM482045H | In distribution | |
| DSLAM402045NS | In distribution | |
| DSLAR481045H | In distribution | |
| DSLAR482045NS | In distribution | |
| DSLAM481045H | In distribution | |
| DSLAR481045NS | In distribution | |
| DSLAM482045N | In distribution | |
| DSLAM401045N | In distribution | |
| DSLAR482045N | In distribution | |
| DSLARC453547HS | In distribution | |
| DSLAR483545N | In distribution | |
| DSLAMC451047HS | In distribution | |
| DSLAR485045HS | In distribution | |
| DSLAMC453047N | In distribution | |
| DSLAM482045HS | In distribution | |
| DSLAM403545N | In distribution | |
| DSLAMC453547H | In distribution | |
| DSLAM405045H | In distribution | |
| DSLAMC453547N | In distribution | |
| DSLARC451047N | In distribution | |
| DSLAMC453047HS | In distribution | |
| DSLARC452047N | In distribution | |
| DSLAMC452047HS | In distribution | |
| DSLAMC452047N | In distribution | |
| DSLAM485045HS | In distribution | |
| DSLAM402045HS | In distribution | |
| DSLAR483545HS | In distribution | |
| DSLARC452047H | In distribution | |
| DSLAM405045NS | In distribution | |
| DSLAMC453547NS | In distribution | |
| DSLAM401045H | In distribution | |
| DSLAM482045NS | In distribution | |
| DSLARC453547H | In distribution | |
| DSLARC453547N | In distribution | |
| DSLAMC452047NS | In distribution | |
| DSLAM485045H | In distribution | |
| DSLAMC451047NS | In distribution | |
| DSLARC452047NS | In distribution | |
| DSLAM483545NS | In distribution | |
| DSLARC452047HS | In distribution | |
| DSLAM402045H | In distribution | |
| DSLARC453547NS | In distribution | |
| DSLAM403545NS | In distribution | |
| DSLAM405045HS | In distribution | |
| DSLAM483545N | In distribution | |
| DSLAM401045HS | In distribution | |
| DSLARC453047NS | In distribution | |
| DSLAM401045NS | In distribution | |
| DSLAMC451047N | In distribution | |
| DSLAM483545HS | In distribution | |
| DSLAR481045HS | In distribution | |
| DSLAM403545HS | In distribution | |
| DSLAR482045HS | In distribution | |
| DSLAM483545H | In distribution | |
| DSLAMC453047NS | In distribution | |
| DSLAR485045N | In distribution | |
| DSLARC453047H | In distribution | |
| DSLAM402045N | In distribution | |
| DSLAR485045NS | In distribution | |
| DSLAR485045H | In distribution | |
| DSLAR481045N | In distribution | |
| DSLAM405045N | In distribution | |
| DSLAM481045HS | In distribution | |
| DSLAR483545NS | In distribution | |
| DSLAM403545H | In distribution | |
| DSLARC453047HS | In distribution | |
| DSLAMC452047H | In distribution | |
| DSLAR483545H | In distribution | |
| DSLARC451047H | In distribution | |
| DSLAM485045N | In distribution | |
| DSLAM485045NS | In distribution | |
| DSLAMC451047H | In distribution | |
| DSLAMC453047H | In distribution | |
| DSLARC451047HS | In distribution | |
| DSLAM481045NS | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241063 | 2024-07-25 |
| K230126 | 2023-08-04 |
| K230307 | 2023-07-11 |
| K230246 | 2023-05-25 |
| K230523 | 2023-05-24 |
| K230203 | 2023-05-03 |
| K222451 | 2023-02-07 |
| K222913 | 2023-01-13 |
| K222976 | 2023-01-12 |
| K220440 | 2022-06-16 |
| K210410 | 2021-09-10 |
| K210362 | 2021-08-19 |
| K171694 | 2017-11-29 |
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.