I-Clean OneQ-SL Fixture
The i-Clean OneQ-SL fixture is a dental implant placed in the bone of the upper or lower jaw to support a tooth restoration. It is intended for partially or fully toothless jaws and for…
The i-Clean OneQ-SL fixture is a dental implant placed in the bone of the upper or lower jaw to support a tooth restoration. It is intended for partially or fully toothless jaws and for delayed loading after placement.
The fixture has an internal octagonal connection and a non-submerged design. It can support single or multiple-unit restorations, including cement-retained or screw-retained restorations, overdentures and fixed bridgework.
Listed Item
Dental Implant System / i-Clean OneQ-SL Fixture Set (Fixture + Cover Screw)
Material and Surface
The fixture is made from commercially pure grade 4 titanium. Its surface is treated by large-grit sandblasting followed by acid etching. The implants are supplied sterile and use gamma sterilization.
7manufacturers in China registered for this device type
133catalogue numbers in this listing
19510(k) clearances naming this product code
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) | K142313 |
| Record published | 2019-05-09 |
| Record revised | 2021-05-26 (version 7) |
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, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DISOF4842142S | In distribution | |
| DISOF6547123S | In distribution | |
| DISOF4847123S | In distribution | |
| DISOF4847103S | In distribution | |
| DISOF4852082S | In distribution | |
| DISOF4847072 | In distribution | |
| DISOF6547142 | In distribution | |
| DISOF4847082 | In distribution | |
| DISOF4842083S | In distribution | |
| DISOF6552082S | In distribution | |
| DISOF4847083 | In distribution | |
| DISOF6542073 | In distribution | |
| DISOF6570102S | In distribution | |
| DISOF4842102 | In distribution | |
| DISOF6570072 | In distribution | |
| DISOF6570122 | In distribution | |
| DISOF6547083 | In distribution | |
| DISOF4847102S | In distribution | |
| DISOF4847143 | In distribution | |
| DISOF4852123S | In distribution | |
| DISOF4837103 | In distribution | |
| DISOF4847143S | In distribution | |
| DISOF6542083 | In distribution | |
| DISOF6547083S | In distribution | |
| DISOF4837083S | In distribution | |
| DISOF4842143S | In distribution | |
| DISOF4842123 | In distribution | |
| DISOF6542143 | In distribution | |
| DISOF4842073S | In distribution | |
| DISOF6542103 | In distribution | |
| DISOF6552142 | In distribution | |
| DISOF4852122S | In distribution | |
| DISOF6547072S | In distribution | |
| DISOF4837102 | In distribution | |
| DISOF4842142 | In distribution | |
| DISOF4842143 | In distribution | |
| DISOF4852072S | In distribution | |
| DISOF4842122 | In distribution | |
| DISOF4837143 | In distribution | |
| DISOF4842103 | In distribution | |
| DISOF4837142 | In distribution | |
| DISOF4847072S | In distribution | |
| DISOF4837102S | In distribution | |
| DISOF6547103S | In distribution | |
| DISOF6552122S | In distribution | |
| DISOF6547102 | In distribution | |
| DISOF4837072S | In distribution | |
| DISOF4852073S | In distribution | |
| DISOF6560072 | In distribution | |
| DISOF6560082 | In distribution | |
| DISOF4847122S | In distribution | |
| DISOF4847073S | In distribution | |
| DISOF4852073 | In distribution | |
| DISOF4837143S | In distribution | |
| DISOF6560122 | In distribution | |
| DISOF4852143S | In distribution | |
| DISOF6542103S | In distribution | |
| DISOF6542143S | In distribution | |
| DISOF4852142S | In distribution | |
| DISOF6542073S | In distribution | |
| DISOF4837073 | In distribution | |
| DISOF4847102 | In distribution | |
| DISOF4842073 | In distribution | |
| DISOF6560102 | In distribution | |
| DISOF4852102 | In distribution | |
| DISOF6560082S | In distribution | |
| DISOF4842082S | In distribution | |
| DISOF4847073 | In distribution | |
| DISOF6547082 | In distribution | |
| DISOF6542123 | In distribution | |
| DISOF4842083 | In distribution | |
| DISOF6560122S | In distribution | |
| DISOF6552122 | In distribution | |
| DISOF4842082 | In distribution | |
| DISOF6552102S | In distribution | |
| DISOF4842103S | In distribution | |
| DISOF4837082S | In distribution | |
| DISOF6547143 | In distribution | |
| DISOF4842102S | In distribution | |
| DISOF6570082S | In distribution | |
| DISOF6547072 | In distribution | |
| DISOF4842122S | In distribution | |
| DISOF6560102S | In distribution | |
| DISOF6547143S | In distribution | |
| DISOF4847142S | In distribution | |
| DISOF4847123 | In distribution | |
| DISOF4837072 | In distribution | |
| DISOF4852122 | In distribution | |
| DISOF4842072 | In distribution | |
| DISOF4847083S | In distribution | |
| DISOF4837103S | In distribution | |
| DISOF6570072S | In distribution | |
| DISOF6570082 | In distribution | |
| DISOF4837142S | In distribution | |
| DISOF4837122S | In distribution | |
| DISOF6552082 | In distribution | |
| DISOF6570122S | In distribution | |
| DISOF4837122 | In distribution | |
| DISOF6547103 | In distribution | |
| DISOF4852072 | In distribution | |
| DISOF6570102 | In distribution | |
| DISOF6547082S | In distribution | |
| DISOF4837082 | In distribution | |
| DISOF4842072S | In distribution | |
| DISOF4852103S | In distribution | |
| DISOF4837083 | In distribution | |
| DISOF4837123 | In distribution | |
| DISOF6547122 | In distribution | |
| DISOF6552102 | In distribution | |
| DISOF4852142 | In distribution | |
| DISOF4837073S | In distribution | |
| DISOF6542123S | In distribution | |
| DISOF4852102S | In distribution | |
| DISOF6547122S | In distribution | |
| DISOF6547073 | In distribution | |
| DISOF4852083 | In distribution | |
| DISOF4847142 | In distribution | |
| DISOF4847082S | In distribution | |
| DISOF6547142S | In distribution | |
| DISOF4852103 | In distribution | |
| DISOF6547102S | In distribution | |
| DISOF6552142S | In distribution | |
| DISOF6547123 | In distribution | |
| DISOF6542083S | In distribution | |
| DISOF4852083S | In distribution | |
| DISOF4852143 | In distribution | |
| DISOF6552072S | In distribution | |
| DISOF4842123S | In distribution | |
| DISOF4852123 | In distribution | |
| DISOF6560072S | In distribution | |
| DISOF4837123S | In distribution | |
| DISOF6547073S | In distribution | |
| DISOF4847122 | 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.