Straumann TLX Implant System
Straumann TLX is a family of tapered dental implants and associated restorative components. The implant fixture anchors in the jaw and connects to a prosthetic restoration through an…
Straumann TLX is a family of tapered dental implants and associated restorative components. The implant fixture anchors in the jaw and connects to a prosthetic restoration through an abutment.
The fixture is made from Roxolid, a titanium-zirconium alloy, with an SLActive surface. Its conical connection has a Torx-style engaging feature that provides the internal interface for matching restorative components.
Listed Item
TLX SP Implant, Ø 3.75mm RT, SLActive® 10mm, Roxolid®
Platforms and Healing Components
Narrow, Regular and Wide TorcFit platforms share the same internal connection design across fixture diameters and lengths. Separate closure and healing caps protect that interface during healing; these caps perform a different role from the abutment that supports the final restoration.
7manufacturers in China registered for this device type
228catalogue numbers in this listing
31510(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 | Institut Straumann AG, Switzerland |
|---|---|
| FDA product code | DZE |
| Device type | Implant, Endosseous, Root-Form |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3640 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K200586 |
| Record published | 2020-11-06 |
| Record revised | 2025-06-16 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight |
| Sizes | Outer diameter 3.75 to 6.5 mm; length 6 to 18 mm |
| Distribution end date | 2024-10-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SLActive Roxolid TL | Length 8 mm | In distribution |
| SLA Roxolid TL | Length 6 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLActive Roxolid TL | Length 12 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 6.5 mm | In distribution |
| SLA Roxolid TL | Length 10 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 5.5 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLActive Roxolid TL | Length 12 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 6.5 mm | In distribution |
| SLActive Roxolid TL | Length 18 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 5.5 mm | In distribution |
| SLA Roxolid TL | Length 14 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLActive Roxolid TL | Length 10 mm | In distribution |
| SLActive Roxolid TL | Length 12 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLActive Roxolid TL | Length 8 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 6.5 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLA Roxolid TL | Length 8 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLActive Roxolid TL | Length 10 mm | In distribution |
| SLActive Roxolid TL | Length 18 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLA Roxolid TL | Length 8 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLActive Roxolid TL | Length 6 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 5.5 mm | In distribution |
| SLActive Roxolid TL | Length 12 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 6.5 mm | In distribution |
| SLActive Roxolid TL | Length 14 mm | In distribution |
| SLActive Roxolid TL | Length 16 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLActive Roxolid TL | Length 8 mm | In distribution |
| SLA Roxolid TL | Length 16 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLActive Roxolid TL | Length 8 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLActive Roxolid TL | Length 8 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLA Roxolid TL | Length 12 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 5.5 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLA Roxolid TL | Length 10 mm | In distribution |
| SLA Roxolid TL | Length 12 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLActive Roxolid TL | Length 6 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 6.5 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 6.5 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLA Roxolid TL | Length 6 mm | In distribution |
| SLActive Roxolid TL | Length 16 mm | In distribution |
| SLActive Roxolid TL | Length 18 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLActive Roxolid TL | Length 6 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLActive Roxolid TL | Length 16 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLA Roxolid TL | Length 18 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 6.5 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 6.5 mm | In distribution |
| SLA Roxolid TL | Length 12 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLActive Roxolid TL | Length 8 mm | In distribution |
| SLA Roxolid TL | Length 16 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLA Roxolid TL | Length 6 mm | In distribution |
| SLActive Roxolid TL | Length 10 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 6.5 mm | In distribution |
| SLA Roxolid TL | Length 8 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLA Roxolid TL | Length 18 mm | In distribution |
| SLActive Roxolid TL | Length 6 mm | In distribution |
| SLA Roxolid TL | Length 8 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 5.5 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLA Roxolid TL | Length 18 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 5.5 mm | In distribution |
| SLA Roxolid TL | Length 10 mm | In distribution |
| SLActive Roxolid TL | Length 6 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLActive Roxolid TL | Length 12 mm | In distribution |
| SLA Roxolid TL | Length 14 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 5.5 mm | In distribution |
| SLA Roxolid TL | Length 14 mm | In distribution |
| SLA Roxolid TL | Length 10 mm | In distribution |
| SLA Roxolid TL | Length 16 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 6.5 mm | In distribution |
| SLA Roxolid TL | Length 6 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 5.5 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLActive Roxolid TL | Length 14 mm | In distribution |
| SLActive Roxolid TL | Length 12 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLActive Roxolid TL | Length 18 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 5.5 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLA Roxolid TL | Length 16 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 6.5 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLA Roxolid TL | Length 18 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 5.5 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLActive Roxolid TL | Length 8 mm | In distribution |
| SLA Roxolid TL | Length 6 mm | In distribution |
| SLA Roxolid TL | Length 12 mm | In distribution |
| SLActive Roxolid TL | Length 16 mm | In distribution |
| SLA Roxolid TL | Length 18 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 5.5 mm | In distribution |
| SLActive Roxolid TL | Length 14 mm | In distribution |
| SLA Roxolid TL | Length 6 mm | In distribution |
| SLActive Roxolid TL | Length 8 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 3.75 mm | In distribution |
| SLA Roxolid TL | Length 8 mm | In distribution |
| SLA Roxolid TL | Length 16 mm | In distribution |
| SLA Roxolid TL | Length 14 mm | In distribution |
| SLA Roxolid TL | Outer Diameter 4.5 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLActive Roxolid TL | Length 6 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 5 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLActive Roxolid TL | Length 14 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLActive Roxolid TL | Length 16 mm | Withdrawn |
| SLA Roxolid TL | Length 18 mm | Withdrawn |
| SLA Roxolid TL | Length 14 mm | Withdrawn |
| SLActive Roxolid TL | Length 16 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLActive Roxolid TL | Length 16 mm | Withdrawn |
| SLA Roxolid TL | Length 14 mm | Withdrawn |
| SLA Roxolid TL | Length 14 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 5 mm | Withdrawn |
| SLActive Roxolid TL | Length 16 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLActive Roxolid TL | Length 10 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLActive Roxolid TL | Length 14 mm | Withdrawn |
| SLActive Roxolid TL | Length 10 mm | Withdrawn |
| SLActive Roxolid TL | Length 8 mm | Withdrawn |
| SLActive Roxolid TL | Length 10 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLA Roxolid TL | Length 8 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 5 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 5 mm | Withdrawn |
| SLA Roxolid TL | Length 18 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 5 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 5 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 5 mm | Withdrawn |
| SLA Roxolid TL | Length 18 mm | Withdrawn |
| SLActive Roxolid TL | Length 14 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 5 mm | Withdrawn |
| SLActive Roxolid TL | Length 6 mm | Withdrawn |
| SLA Roxolid TL | Length 10 mm | Withdrawn |
| SLActive Roxolid TL | Length 18 mm | Withdrawn |
| SLA Roxolid TL | Length 16 mm | Withdrawn |
| SLActive Roxolid TL | Length 16 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLA Roxolid TL | Length 8 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 5 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 5 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 5 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 5 mm | Withdrawn |
| SLA Roxolid TL | Length 6 mm | Withdrawn |
| SLA Roxolid TL | Length 6 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLA Roxolid TL | Length 10 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 5 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLA Roxolid TL | Length 8 mm | Withdrawn |
| SLA Roxolid TL | Length 18 mm | Withdrawn |
| SLA Roxolid TL | Length 12 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLA Roxolid TL | Length 12 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 5 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 5 mm | Withdrawn |
| SLActive Roxolid TL | Length 6 mm | Withdrawn |
| SLA Roxolid TL | Length 6 mm | Withdrawn |
| SLActive Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLA Roxolid TL | Outer Diameter 4 mm | Withdrawn |
| SLA Roxolid TL | Length 12 mm | Withdrawn |
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 |
|---|---|
| K252168 | 2026-03-10 |
| K250294 | 2025-08-12 |
| K241391 | 2024-12-10 |
| K234049 | 2024-03-20 |
| K230108 | 2023-09-14 |
| K223083 | 2023-06-22 |
| K212533 | 2022-01-28 |
| K211052 | 2021-07-08 |
| K210855 | 2021-06-21 |
| K200586 | 2020-08-20 |
| K191256 | 2019-12-27 |
| K191895 | 2019-12-09 |
| K180477 | 2019-01-04 |
| K181703 | 2018-12-28 |
| K173961 | 2018-06-05 |
| K153758 | 2016-03-23 |
| K081419 | 2009-02-20 |
| K062129 | 2006-10-20 |
| K061176 | 2006-08-11 |
| K053088 | 2006-02-27 |
| K033984 | 2004-06-30 |
| K033922 | 2004-01-07 |
| K020096 | 2002-02-08 |
| K013891 | 2002-02-05 |
| K013798 | 2001-12-19 |
| K003552 | 2001-08-17 |
| K003271 | 2001-03-20 |
| K983742 | 1999-03-15 |
| K894595 | 1990-02-13 |
| K894594 | 1990-02-13 |
| K894593 | 1990-02-13 |
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.