Straumann® BLC and TLC Implants – Line Extension
The Straumann TLC Standard Plus implant is a screw-form dental implant for supporting crowns, bridges or dentures in partially or fully edentulous jaws. Its bone-contact surface is…
The Straumann TLC Standard Plus implant is a screw-form dental implant for supporting crowns, bridges or dentures in partially or fully edentulous jaws. Its bone-contact surface is large-grit sandblasted and acid-etched. The SLActive surface is chemically activated and stored in saline to preserve that state.
The line extension includes 5.5 mm TLC implants in 14 and 16 mm lengths with a Wide TorcFit platform. Standard Plus uses a 1.8 mm neck, distinct from the 2.8 mm Standard neck. The listed 16 mm Standard Plus configuration belongs to this extension.
Listed Item
TLC SP Implant, Ø 5.5mm WT, SLActive 16mm, Roxolid
Placement and Loading
Implantation may follow tooth extraction immediately, early or later. Immediate function requires good primary stability and appropriate occlusal loading. The line extension also introduces X-ray irradiation as a sterilization method, without changing the implant’s role as a support for a connected prosthesis.
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) | K234049 |
| Record published | 2024-05-03 |
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 5.5 to 6.5 mm; length 8 to 16 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SLActive Roxolid TL | Outer Diameter 6.5 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 5.5 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 6.5 mm | In distribution |
| SLActive Roxolid BL | Length 16 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 5.5 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 5.5 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 6.5 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 6.5 mm | In distribution |
| SLActive Roxolid TL | Outer Diameter 5.5 mm | In distribution |
| SLActive Roxolid TL | Length 16 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 14 mm | 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 |
|---|---|
| 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.