S-Clean SQ-SL Fixture
s-Clean SQ-SL Fixture is a threaded dental implant body made from commercially pure Grade 4 titanium. It is placed in mandibular or maxillary bone and connects internally to the restorative…
s-Clean SQ-SL Fixture is a threaded dental implant body made from commercially pure Grade 4 titanium. It is placed in mandibular or maxillary bone and connects internally to the restorative abutment.
The fixture has a tapered body and a self-tapping cutting edge. Its surface is treated by large-grit sandblasting and acid etching, while the internal hexagonal connection receives the compatible abutment.
Listed Item
Dental Implant System / s-Clean SQ-SL Fixture (DSSFR5507)
Fixture and Restorative Components
The system includes separate Sole and TiN-coated Sole abutments that support the dental prosthesis. A cover screw protects the implant’s internal connection during healing. The fixture and cover screw use commercially pure titanium, while the restorative abutments use Ti-6Al-4V ELI titanium alloy.
Who Else Makes It
Concentrated in Jiangsu (3), Sichuan (2), Shanghai (1). 5 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 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Basic (Chengdu) Medical Device Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 1 |
| Dongguan Xinlonghong Hardware Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 1 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| BIO Concept Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 5 |
Record
| Listed by | Dentis Co., Ltd., South Korea |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K192688 |
| Record published | 2020-04-23 |
| Record revised | 2021-05-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DSSFR4507 | In distribution | |
| DSSFW6008 | In distribution | |
| DSSFW6008S | In distribution | |
| DSSFR5507 | In distribution | |
| DSSFR4007S | In distribution | |
| DSSFW7008S | In distribution | |
| DSSFW7012S | In distribution | |
| DSSFW7010 | In distribution | |
| DSSFR4512S | In distribution | |
| DSSFR4012S | In distribution | |
| DSSFR5018S | In distribution | |
| DSSFR5516S | In distribution | |
| DSSFW6007S | In distribution | |
| DSSFR5012 | In distribution | |
| DSSFR4516 | In distribution | |
| DSSFR4007 | In distribution | |
| DSSFW6007 | In distribution | |
| DSSFR5512S | In distribution | |
| DSSFR4516S | In distribution | |
| DSSFR4518S | In distribution | |
| DSSFR5507S | In distribution | |
| DSSFR5518S | In distribution | |
| DSSFW8012 | In distribution | |
| DSSFW7008 | In distribution | |
| DSSFR5516 | In distribution | |
| DSSFR5508 | In distribution | |
| DSSFR5008S | In distribution | |
| DSSFR5016S | In distribution | |
| DSSFR5510 | In distribution | |
| DSSFW8010S | In distribution | |
| DSSFR4514S | In distribution | |
| DSSFR5014 | In distribution | |
| DSSFW6012 | In distribution | |
| DSSFR5514S | In distribution | |
| DSSFR5014S | In distribution | |
| DSSFR4012 | In distribution | |
| DSSFR5016 | In distribution | |
| DSSFR4512 | In distribution | |
| DSSFW8010 | In distribution | |
| DSSFW7007S | In distribution | |
| DSSFR4008S | In distribution | |
| DSSFR5512 | In distribution | |
| DSSFR4514 | In distribution | |
| DSSFR5018 | In distribution | |
| DSSFR5507 | In distribution | |
| DSSFR5007S | In distribution | |
| DSSFW7007 | In distribution | |
| DSSFR4010S | In distribution | |
| DSSFR5010 | In distribution | |
| DSSFR4508 | In distribution | |
| DSSFR4010 | In distribution | |
| DSSFW6010 | In distribution | |
| DSSFR4008 | In distribution | |
| DSSFR4510S | In distribution | |
| DSSFR5518 | In distribution | |
| DSSFR4510 | In distribution | |
| DSSFR5010S | In distribution | |
| DSSFR5510S | In distribution | |
| DSSFR5508S | In distribution | |
| DSSFW8012S | In distribution | |
| DSSFR4508S | In distribution | |
| DSSFR5008 | In distribution | |
| DSSFR5007 | In distribution | |
| DSSFW8008S | In distribution | |
| DSSFR5012S | In distribution | |
| DSSFR4014 | In distribution | |
| DSSFW7010S | In distribution | |
| DSSFW6010S | In distribution | |
| DSSFW8007S | In distribution | |
| DSSFR4014S | In distribution | |
| DSSFR5514 | In distribution | |
| DSSFR4507S | In distribution | |
| DSSFW6012S | In distribution | |
| DSSFW8008 | In distribution | |
| DSSFR4518 | In distribution | |
| DSSFW8007 | In distribution | |
| DSSFW7012 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 920 |
| Osstem Implant System | Osstem Implant Co., Ltd. | 788 |
| Magicore | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 744 |
| Implant, Endosseous, Root-Form | Southern Implants (PTY) Ltd | 608 |
| ITL Dental | Emery Enterprises Inc. | 603 |
| Magicore S | InnoBioSurg Co., Ltd.(IBS implant Co., Ltd.) | 560 |
| Friadent® | Dentsply Implants Manufacturing GmbH | 525 |
| Sphero Block Normo | Rhein 83 SRL | 489 |
| Neobiotech Implant System | Neobiotech Co., Ltd. | 483 |
| KJ Mini Implant System | Kjmeditech.co., Ltd. | 448 |
| Ritter Dental Implant System | Ritter Implants GmbH & Co. KG | 418 |
| Leone SPA | Leone SPA | 404 |
Showing 12 of 2,762. All products under Implant, Endosseous, Root-Form
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253493 | 2026-03-04 |
| K240511 | 2024-05-20 |
| K210080 | 2021-06-04 |
| K210134 | 2021-04-19 |
| K202773 | 2021-03-18 |
| K210132 | 2021-02-17 |
| K200099 | 2020-04-13 |
| K192688 | 2020-02-04 |
| K171027 | 2017-09-06 |
| K170220 | 2017-04-27 |
| K161244 | 2016-12-07 |
| K160213 | 2016-06-21 |
| K153639 | 2016-04-08 |
| K142313 | 2015-12-10 |
| K150344 | 2015-07-24 |
| K111364 | 2012-02-01 |
| K082843 | 2009-06-19 |
| K083586 | 2009-04-29 |
| K073486 | 2008-04-04 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P800035 | 2001-10-04 | PERI-OSS | Curasan AG |
| P860012 | 1988-10-28 | ALVEOFORM TM BIOGRAFT | Collagen Corp. |
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.