Straumann BLX Ø3.5 Mm Implants
Straumann BLX 3.5 mm implants are fully tapered dental implants placed in the upper or lower jaw to support replacement teeth. The listed SLActive configuration uses Roxolid material and a…
Straumann BLX 3.5 mm implants are fully tapered dental implants placed in the upper or lower jaw to support replacement teeth. The listed SLActive configuration uses Roxolid material and a Regular Base prosthetic platform.
The internal TorcFit connection combines a conical fit with a Torx-style engaging feature. Matching abutments connect the implant to the prosthetic restoration, with the connection shared across the available implant lengths.
Listed Item
BLX Implant, Ø 3.5mm RB, SLActive® 12mm, Roxolid®
Restoration and Loading
The 3.5 mm range includes lengths from 8 to 18 mm and is supplied sterile after gamma irradiation. BLX implants can support single-tooth, bar or bridge restorations. Immediate function is an option when adequate primary stability is achieved and the planned bite loading is appropriate.
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) | K191256 |
| Record published | 2022-04-14 |
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 3.5 mm; length 8 to 18 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SLActive Roxolid BL | Outer Diameter 3.5 mm | In distribution |
| SLA Roxolid BL | Length 10 mm | In distribution |
| SLA Roxolid BL | Outer Diameter 3.5 mm | In distribution |
| SLA Roxolid BL | Length 8 mm | In distribution |
| SLActive Roxolid BL | Length 10 mm | In distribution |
| SLA Roxolid BL | Outer Diameter 3.5 mm | In distribution |
| SLActive Roxolid BL | Length 18 mm | In distribution |
| SLActive Roxolid BL | Length 8 mm | In distribution |
| SLA Roxolid BL | Outer Diameter 3.5 mm | In distribution |
| SLActive Roxolid BL | Length 16 mm | In distribution |
| SLA Roxolid BL | Outer Diameter 3.5 mm | In distribution |
| SLActive Roxolid BL | 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.