S-Clean TiN Half Coating Couple Abutment
The s-Clean TiN Half Coating Couple Abutment is a dental prosthetic component used with compatible Dentis implants to support a restoration in the upper or lower jaw. The listed…
The s-Clean TiN Half Coating Couple Abutment is a dental prosthetic component used with compatible Dentis implants to support a restoration in the upper or lower jaw. The listed configuration has a 4.5 mm diameter and a 5.3 mm cuff height.
Its titanium alloy body has a titanium nitride coating over half of the surface, applied by physical vapor deposition. The Couple Abutment belongs to a range with different diameters and cuff heights for the implant and restoration configuration.
Listed Item
Dental Implant System / s-Clean TiN Half Coating Couple Abutment D4.5mm, Cuff5.3mm / Non-Hex
Preparation and Compatibility
The abutment is supplied nonsterile and requires steam sterilization by the user before placement. Compatibility is limited to the specified Dentis implant systems and their corresponding connection dimensions.
15manufacturers in China registered for this device type
146catalogue numbers in this listing
13510(k) clearances naming this product code
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) | K171694 |
| Record published | 2019-05-14 |
| Record revised | 2021-05-26 (version 4) |
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, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DSCA5535HHCT | In distribution | |
| DSCA4555NHCT | In distribution | |
| DSCA6510N4HCT | In distribution | |
| DSCA4545N7HCT | In distribution | |
| DSCA5515NHCT | In distribution | |
| DSCA5555HHCT | In distribution | |
| DSCA605NHCT | In distribution | |
| DSCA5535H7HCT | In distribution | |
| DSCA6555N7HCT | In distribution | |
| DSCA6510H4HCT | In distribution | |
| DSCA4510H7HCT | In distribution | |
| DSCA484HHCT | In distribution | |
| DSCA6535N7HCT | In distribution | |
| DSCA4535HHCT | In distribution | |
| DSCA5520N4HCT | In distribution | |
| DSCA6520H7HCT | In distribution | |
| DSCA6555N4HCT | In distribution | |
| DSCA601NHCT | In distribution | |
| DSCA6520N4HCT | In distribution | |
| DSCA4510N7HCT | In distribution | |
| DSCA601HHCT | In distribution | |
| DSCA4535H7HCT | In distribution | |
| DSCA5515N7HCT | In distribution | |
| DSCA5545N7HCT | In distribution | |
| DSCA4545NHCT | In distribution | |
| DSCA4525H4HCT | In distribution | |
| DSCA485HHCT | In distribution | |
| DSCA603NHCT | In distribution | |
| DSCA4515H7HCT | In distribution | |
| DSCA6520H4HCT | In distribution | |
| DSCA4525H7HCT | In distribution | |
| DSCA6545N7HCT | In distribution | |
| DSCA5510H4HCT | In distribution | |
| DSCA4535N7HCT | In distribution | |
| DSCA4520H7HCT | In distribution | |
| DSCA5535NHCT | In distribution | |
| DSCA5525H7HCT | In distribution | |
| DSCA6525HHCT | In distribution | |
| DSCA4555H7HCT | In distribution | |
| DSCA4525HHCT | In distribution | |
| DSCA5535N4HCT | In distribution | |
| DSCA6520N7HCT | In distribution | |
| DSCA6510H7HCT | In distribution | |
| DSCA6520HHCT | In distribution | |
| DSCA485NHCT | In distribution | |
| DSCA6555NHCT | In distribution | |
| DSCA4520N7HCT | In distribution | |
| DSCA5545HHCT | In distribution | |
| DSCA5525HHCT | In distribution | |
| DSCA4520H4HCT | In distribution | |
| DSCA5515H4HCT | In distribution | |
| DSCA5555H7HCT | In distribution | |
| DSCA5520NHCT | In distribution | |
| DSCA4535N4HCT | In distribution | |
| DSCA4510N4HCT | In distribution | |
| DSCA6545H7HCT | In distribution | |
| DSCA5515H7HCT | In distribution | |
| DSCA4535H4HCT | In distribution | |
| DSCA5520H7HCT | In distribution | |
| DSCA6535HHCT | In distribution | |
| DSCA5555H4HCT | In distribution | |
| DSCA6535NHCT | In distribution | |
| DSCA5525N7HCT | In distribution | |
| DSCA6535H7HCT | In distribution | |
| DSCA6525N7HCT | In distribution | |
| DSCA4525N4HCT | In distribution | |
| DSCA6525H4HCT | In distribution | |
| DSCA5535N7HCT | In distribution | |
| DSCA482HHCT | In distribution | |
| DSCA604NHCT | In distribution | |
| DSCA6555H7HCT | In distribution | |
| DSCA4520NHCT | In distribution | |
| DSCA6515HHCT | In distribution | |
| DSCA4555HHCT | In distribution | |
| DSCA5520N7HCT | In distribution | |
| DSCA5510H7HCT | In distribution | |
| DSCA4515HHCT | In distribution | |
| DSCA4545H4HCT | In distribution | |
| DSCA481HHCT | In distribution | |
| DSCA6515N4HCT | In distribution | |
| DSCA6510NHCT | In distribution | |
| DSCA6555HHCT | In distribution | |
| DSCA4555H4HCT | In distribution | |
| DSCA4555N7HCT | In distribution | |
| DSCA6545NHCT | In distribution | |
| DSCA6525N4HCT | In distribution | |
| DSCA4515NHCT | In distribution | |
| DSCA5515N4HCT | In distribution | |
| DSCA5545NHCT | In distribution | |
| DSCA6535H4HCT | In distribution | |
| DSCA5555NHCT | In distribution | |
| DSCA6520NHCT | In distribution | |
| DSCA6525NHCT | In distribution | |
| DSCA602HHCT | In distribution | |
| DSCA5545H4HCT | In distribution | |
| DSCA482NHCT | In distribution | |
| DSCA5510N4HCT | In distribution | |
| DSCA5510NHCT | In distribution | |
| DSCA5515HHCT | In distribution | |
| DSCA484NHCT | In distribution | |
| DSCA5545H7HCT | In distribution | |
| DSCA4525NHCT | In distribution | |
| DSCA6545HHCT | In distribution | |
| DSCA4520HHCT | In distribution | |
| DSCA4510H4HCT | In distribution | |
| DSCA4545N4HCT | In distribution | |
| DSCA4510HHCT | In distribution | |
| DSCA5555N4HCT | In distribution | |
| DSCA4515N4HCT | In distribution | |
| DSCA6515N7HCT | In distribution | |
| DSCA6510HHCT | In distribution | |
| DSCA481NHCT | In distribution | |
| DSCA5525NHCT | In distribution | |
| DSCA5545N4HCT | In distribution | |
| DSCA6545H4HCT | In distribution | |
| DSCA5535H4HCT | In distribution | |
| DSCA5510HHCT | In distribution | |
| DSCA5525H4HCT | In distribution | |
| DSCA5555N7HCT | In distribution | |
| DSCA4510NHCT | In distribution | |
| DSCA6535N4HCT | In distribution | |
| DSCA4520N4HCT | In distribution | |
| DSCA5520H4HCT | In distribution | |
| DSCA6555H4HCT | In distribution | |
| DSCA4545H7HCT | In distribution | |
| DSCA4515H4HCT | In distribution | |
| DSCA604HHCT | In distribution | |
| DSCA6525H7HCT | In distribution | |
| DSCA5510N7HCT | In distribution | |
| DSCA605HHCT | In distribution | |
| DSCA483HHCT | In distribution | |
| DSCA4535NHCT | In distribution | |
| DSCA6510N7HCT | In distribution | |
| DSCA6515H7HCT | In distribution | |
| DSCA6515NHCT | In distribution | |
| DSCA5520HHCT | In distribution | |
| DSCA4555N4HCT | In distribution | |
| DSCA4545HHCT | In distribution | |
| DSCA603HHCT | In distribution | |
| DSCA6515H4HCT | In distribution | |
| DSCA602NHCT | In distribution | |
| DSCA4515N7HCT | In distribution | |
| DSCA5525N4HCT | In distribution | |
| DSCA6545N4HCT | In distribution | |
| DSCA4525N7HCT | In distribution | |
| DSCA483NHCT | 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.