Straumann Bone Level
Also known as: BL, Straumann BL, Straumann Bone Level Implant
The parallel-walled bone-level implant in the Straumann Dental Implant System, using the CrossFit connection and intended for placement at bone level with trans- or subgingival healing.
Quick facts
| Current status | Current. The Bone Level implant is one of three bone-level lines (BL, BLT, BLX) shown in Straumann’s Bone Level Tapered documentation revised January 2025.Manufacturer-reported[1][2] |
|---|---|
| Implant level | Bone level. The rough surface extends to the top of the implant and the connection is shifted inwards.Manufacturer-reported[1] |
| Body geometry | Cylindrical outer contour — a parallel-walled endosteal design.Manufacturer-reported[1] |
| Thread design | Thread pitch 0.8 mm, tapering off in the coronal part of the implant.Manufacturer-reported[1] |
| Apex design | Manufacturer documentation not located(The Basic Information document does not give a separate apex specification for the parallel-walled Bone Level implant.) |
| Material | Roxolid with the SLActive or SLA surface, or titanium with an SLA surface.Manufacturer-reported[1] |
| Surface | SLActive or SLA.Manufacturer-reported[1] |
| Connection | CrossFit — a 15° conical-cylindrical connection with four internal grooves. Narrow CrossFit (NC) on ∅ 3.3 mm implants; Regular CrossFit (RC) on ∅ 4.1 and ∅ 4.8 mm implants, which share the same secondary components.Manufacturer-reported[1] |
| Platform switching | Straumann describes the connection as shifted inwards relative to the implant shoulder, with the rough surface extending to the top of the implant.Manufacturer-reported[1] |
| Available diameters | Endosteal diameter ∅ 3.3, 4.1 and 4.8 mm.Manufacturer-reported[1] |
| Available lengths | 8–14 mm across all three diameters.Manufacturer-reported[1] |
Overview
Technology
Clinical positioning
What the manufacturer says this system is designed for. This is not the same thing as independent clinical evidence, which is set out separately below.
Clinical evidence
We have not yet completed a system-specific evidence review for Straumann Bone Level. Insufficient system-specific evidence How we grade evidence
Similar implant systems
Popular comparisons
The clearances below are held by Straumann at brand level and cover its implant range, not Straumann Bone Level specifically. We show them here because that is the level at which regulators actually issue them.
Regulatory record
Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →
FDA 510(k) clearance30 records
Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.
| Number | Device | Holder | Date |
|---|---|---|---|
| K252168 | Straumann® BLC Implants - Indication Widening | Institut Straumann AG | 2026-03-10 |
| K250294 | Straumann® RidgeFit Implants | Institut Straumann AG | 2025-08-12 |
| K241391 | Straumann® PURE Ceramic Implants | Institut Straumann AG | 2024-12-10 |
| K234049 | Straumann® BLC and TLC Implants - Line extension | Institut Straumann AG | 2024-03-20 |
| K230108 | Straumann® BLC and TLC Implants | Institut Straumann AG | 2023-09-14 |
| K223083 | Straumann SLActive labeling changes | Institut Straumann AG | 2023-06-22 |
| K211052 | Straumann RidgeFit Implants | Institut Straumann AG | 2021-07-08 |
| K210855 | Straumann BLX Implant System | Institut Straumann AG | 2021-06-21 |
| K202942 | Straumann 4 mm Short Implants | Straumann USA, LLC | 2021-02-08 |
| K200586 | Straumann TLX Implant System | Institut Straumann AG | 2020-08-20 |
| K191256 | Straumann BLX Ø3.5 mm Implants | Institut Straumann AG | 2019-12-27 |
| K191895 | Straumann Mini Implants | Institut Straumann AG | 2019-12-09 |
| K190662 | MRI Compatibility for Existing Straumann Dental Implant Systems | Straumann USA, LLC | 2019-06-17 |
| K180477 | Straumann PURE Ceramic Implant System | Institut Straumann AG | 2019-01-04 |
| K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments | Institut Straumann AG | 2018-12-28 |
| K173961 | Straumann BLX Implant System | Institut Straumann AG | 2018-06-05 |
| K171784 | Straumann Dental Implant System | Straumann USA, LLC | 2018-01-19 |
| K171769 | Straumann PURE Ceramic Implants | Straumann USA, LLC (On Behalf of Institut Straumann Ag) | 2017-11-14 |
| K153758 | Straumann Bone Level Tapered Implants | Institut Straumann AG | 2016-03-23 |
| K150938 | Straumann® Dental Implant System ¿ Roxolid® SLA Implants | Straumann USA, LLC | 2015-07-24 |
| K140878 | STRAUMANN BONE LEVEL TAPERED IMPLANT | Straumann USA, LLC | 2014-08-20 |
| K130222 | STRAUMANN DENTAL IMPLANT SYSTEM | Straumann USA, LLC | 2013-04-29 |
| K123784 | STRAUMANN DENTAL IMPLANT SYSTEM | Straumann USA, LLC | 2013-04-10 |
| K111357 | STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM | Straumann USA | 2011-10-03 |
| K093027 | STRAUMANN RC TEMPORARY ABUTMENTS | Straumann USA | 2010-02-12 |
| K083550 | STRAUMANN DENTAL IMPLANT SYSTEM | Straumann USA | 2009-02-26 |
| K081419 | STRAUMANN DENTAL IMPLANT SYSTEM | Institut Straumann AG | 2009-02-20 |
| K060958 | STRAUMANN NARROW NECK IMPLANTS | Straumann USA | 2006-08-24 |
| K061176 | STRAUMANN DENTAL IMPLANTS | Institut Straumann AG | 2006-08-11 |
| K033984 | STRAUMANN DENTAL IMPLANT SYSTEM | Institut Straumann AG | 2004-06-30 |
Other1 record
Of 100 records we inspected, 93 are supplied sterile, 7 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (52); MR Conditional (48). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.
| Number | Device | Holder | Date |
|---|---|---|---|
| 1219 device records | — | Straumann | — |
Clearance records for Straumann were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to Straumann.
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]Straumann Dental Implant System — Basic Information (702084/en) — Institut Straumann AG, 2025. Accessed 2026-07-21.
- [2]Straumann Bone Level Tapered Implant — Technical Information (702167/en) — Institut Straumann AG. Accessed 2026-07-21.