Straumann Bone Level Tapered Implants
Straumann Bone Level Tapered Implants support dental restorations in partially or completely edentulous upper and lower jaws. Crowns, bridges or partial and full dentures connect through…
Straumann Bone Level Tapered Implants support dental restorations in partially or completely edentulous upper and lower jaws. Crowns, bridges or partial and full dentures connect through compatible abutments. The implants can be placed immediately or early after tooth extraction.
The implant body is made from Roxolid titanium zirconium alloy containing 13% zirconium. The 18 mm implants use Narrow or Regular CrossFit abutment connections and are offered with SLA or SLActive surface finishes.
Listed Item
Bone Level Tapered Implant, D3.3mm NC, SLActive® 18mm, Roxolid®, Loxim™
Loading Conditions
Immediate function in single or multiple tooth applications requires good primary stability and appropriate occlusal loading. The implants are available in 3.3, 4.1 and 4.8 mm diameters; the coronal thread has a 0.8 mm pitch.
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) | K153758 |
| Record published | 2016-04-13 |
| Record revised | 2023-04-21 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from light and sun |
| Sizes | Length 18 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SLA Roxolid BL | Length 18 mm | In distribution |
| SLA Roxolid BL | Length 18 mm | In distribution |
| SLActive Roxolid BL | Length 18 mm | In distribution |
| SLActive Roxolid BL | Length 18 mm | In distribution |
| SLA Roxolid BL | Length 18 mm | In distribution |
| SLActive Roxolid BL | Length 18 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.