S-Clean Angled Abutment
s-Clean Angled Abutment connects a compatible dental implant fixture to a prosthetic restoration. Its angled form provides the restorative connection above the implant while supporting the…
s-Clean Angled Abutment connects a compatible dental implant fixture to a prosthetic restoration. Its angled form provides the restorative connection above the implant while supporting the replacement tooth structure.
The abutment is Ti-6Al-4V ELI titanium alloy with an internal hexagonal connection. The range includes 15-degree and 25-degree forms, with diameters of 4.5, 5.5 and 6.5 mm.
Listed Item
Dental Implant System / s-Clean Angled Abutment D4.5mm, Cuff1.8mm, Angulation25° / Hex / Edge Type
Fixture and Cuff Options
The compatible fixture family is s-Clean SQ-SL. Abutment gingival-height options are 0.8, 1.8 and 3.8 mm; a listed 25-degree, 4.5 mm abutment with a 1.8 mm cuff is one configuration. The abutments are supplied nonsterile for end-user sterilization.
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) | K230126 |
| Record published | 2023-08-09 |
| Record revised | 2021-05-26 (version 8) |
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 |
|---|---|---|
| DSAA65152NS | In distribution | |
| DSAA45254F | In distribution | |
| DSAA55151S | In distribution | |
| DSAA45252 | In distribution | |
| DSAA65252F | In distribution | |
| DSAA65154F | In distribution | |
| DSAA45252S | In distribution | |
| DSAA45154NS | In distribution | |
| DSAA55154FS | In distribution | |
| DSAA65252S | In distribution | |
| DSAA50152 | In distribution | |
| DSAA65151 | In distribution | |
| DSAA45151N | In distribution | |
| DSAA65251 | In distribution | |
| DSAA55254N | In distribution | |
| DSAA50254 | In distribution | |
| DSAA45252NS | In distribution | |
| DSAA55152NS | In distribution | |
| DSAA55254NS | In distribution | |
| DSAA55252NS | In distribution | |
| DSAA65251NS | In distribution | |
| DSAA65254NS | In distribution | |
| DSAA45154 | In distribution | |
| DSAA55252F | In distribution | |
| DSAA55252FS | In distribution | |
| DSAA55152N | In distribution | |
| DSAA45252F | In distribution | |
| DSAA65254 | In distribution | |
| DSAA45154S | In distribution | |
| DSAA65154FS | In distribution | |
| DSAA55251S | In distribution | |
| DSAA45254NS | In distribution | |
| DSAA45254S | In distribution | |
| DSAA65151S | In distribution | |
| DSAA45152N | In distribution | |
| DSAA65252FS | In distribution | |
| DSAA45254N | In distribution | |
| DSAA55251NS | In distribution | |
| DSAA55251N | In distribution | |
| DSAA45152NS | In distribution | |
| DSAA55152S | In distribution | |
| DSAA45251S | In distribution | |
| DSAA65251S | In distribution | |
| DSAA45152S | In distribution | |
| DSAA65254N | In distribution | |
| DSAA45152 | In distribution | |
| DSAA45154FS | In distribution | |
| DSAA45251 | In distribution | |
| DSAA65252N | In distribution | |
| DSAA55152FS | In distribution | |
| DSAA55252 | In distribution | |
| DSAA65254FS | In distribution | |
| DSAA55152 | In distribution | |
| DSAA65154S | In distribution | |
| DSAA55154F | In distribution | |
| DSAA55152F | In distribution | |
| DSAA55151N | In distribution | |
| DSAA65254S | In distribution | |
| DSAA55252S | In distribution | |
| DSAA45254 | In distribution | |
| DSAA55254F | In distribution | |
| DSAA65154 | In distribution | |
| DSAA50252 | In distribution | |
| DSAA55254 | In distribution | |
| DSAA55154N | In distribution | |
| DSAA65254F | In distribution | |
| DSAA65251N | In distribution | |
| DSAA55251 | In distribution | |
| DSAA45152F | In distribution | |
| DSAA65152F | In distribution | |
| DSAA55254S | In distribution | |
| DSAA65152FS | In distribution | |
| DSAA55154S | In distribution | |
| DSAA65252 | In distribution | |
| DSAA45151 | In distribution | |
| DSAA45254FS | In distribution | |
| DSAA55154NS | In distribution | |
| DSAA45151S | In distribution | |
| DSAA65152S | In distribution | |
| DSAA45251NS | In distribution | |
| DSAA55254FS | In distribution | |
| DSAA65151NS | In distribution | |
| DSAA55252N | In distribution | |
| DSAA55151NS | In distribution | |
| DSAA55151 | In distribution | |
| DSAA65154N | In distribution | |
| DSAA45151NS | In distribution | |
| DSAA65252NS | In distribution | |
| DSAA65151N | In distribution | |
| DSAA65154NS | In distribution | |
| DSAA65152N | In distribution | |
| DSAA45252FS | In distribution | |
| DSAA45152FS | In distribution | |
| DSAA50154 | In distribution | |
| DSAA45154N | In distribution | |
| DSAA65152 | In distribution | |
| DSAA45252N | In distribution | |
| DSAA45154F | 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.