Implant system · Straumann
Straumann BLX
VerifiedLast verified 27 Sept 2026 · data version 1
Quick answer
Straumann BLX is a dental implant system from Straumann (Institut Straumann AG, part of Straumann Group). It is made of titanium–13 zirconium alloy with a SLActive® (hydrophilic) or SLA® surface and uses a torcfit™ connection. We link 5 FDA 510(k) records to this system. Open any value below to see its source.
Manufacturer
- Brand
- Straumann
- Manufacturer (regulatory name)
- Institut Straumann AG
- Corporate group
- Straumann Group
- Headquarters country
- Switzerland (headquarters, not necessarily the place of manufacture)
- Status
- Currently marketed
- Also known as
- BLX, Straumann BLX, BLX Roxolid SLActive
Implant type
| Implant levelWhere the top of the implant sits: level with the bone, or higher up in the gum. | Bone level Manufacturer-stated Manufacturer documentation1 source · verified 27 Sept 2026 |
|---|---|
| Body shapeThe overall shape of the screw that goes into the jaw. | Fully tapered body Regulatory record1 source · verified 27 Sept 2026 |
Material & surface
| MaterialWhat the implant screw itself is made of. | Titanium–13 zirconium alloy (Roxolid®) Regulatory recordManufacturer documentation2 sources · verified 27 Sept 2026 |
|---|---|
| Material grade | Not verified |
| SurfaceHow the outer surface is treated so bone can grow onto it. | SLActive® (hydrophilic) or SLA® Manufacturer-stated The 2024 technical document lists both SLActive and SLA article numbers. Market availability of each surface varies by country. Manufacturer documentationRegulatory record2 sources · verified 27 Sept 2026 |
Connection
| ConnectionHow the visible tooth part (abutment) attaches to the implant. | TorcFit™ — conical connection with Torx-style engaging feature Manufacturer documentationRegulatory record2 sources · verified 27 Sept 2026 |
|---|---|
| Connection angle | 7° conical prosthetic connection (plus 22.5° shoulder on WB) Manufacturer-stated Manufacturer documentation1 source · verified 27 Sept 2026 |
| Anti-rotation index | 6 positions (Torx-style) Manufacturer-stated Manufacturer documentation1 source · verified 27 Sept 2026 |
| Prosthetic platforms | RB (Regular Base, neck Ø3.5 mm) and WB (Wide Base, neck Ø4.5 mm); identical inner connection for all diameters Manufacturer documentationRegulatory record2 sources · verified 27 Sept 2026 |
Size range
| DiametersHow thick the implant is. Your dentist chooses based on your bone. | Ø3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 mm (endosteal) Manufacturer-stated Manufacturer documentation1 source · verified 27 Sept 2026 |
|---|---|
| LengthsHow long the implant is. Shorter ones are used where there is less bone. | 6, 8, 10, 12, 14, 16, 18 mm Manufacturer-stated Not every length exists in every diameter: 6 mm is not listed for Ø3.5; 18 mm is listed up to Ø5.0 only. Manufacturer documentation1 source · verified 27 Sept 2026 |
Macrogeometry · technical detail for dentists
| Thread design | Self-cutting threads; pitch 1.7–3.1 mm depending on diameter and length Manufacturer-stated Manufacturer documentation1 source · verified 27 Sept 2026 |
|---|---|
| Apex | 2 or 4 apical cutting edges depending on diameter Manufacturer-stated Manufacturer documentation1 source · verified 27 Sept 2026 |
| Neck / collar | Neck height 1.0–2.0 mm with micro-threads (0.5–1.0 mm), varying by length Manufacturer-stated Manufacturer documentation1 source · verified 27 Sept 2026 |
Indications
| Immediate function (labeling)Whether a temporary tooth may be fitted on the same day, according to official labeling. What the regulatory labeling permits. It is not evidence that immediate loading works better with this system. | US labeling: immediate function on single-tooth applications when good primary stability and appropriate occlusal loading are achieved Labeling wording, not evidence of clinical superiority. Regulatory record1 source · verified 27 Sept 2026 |
|---|---|
| Restrictions & cautions | Manufacturer advises particular care placing Ø3.5 mm implants in molar or other high-load situations Manufacturer-stated Manufacturer documentation1 source · verified 27 Sept 2026 |
Surgical protocol · technical detail for dentists
| Max insertion torque | Not verified |
|---|
Regulatory records
| Record | Device name (as filed) | Applicant | Decision | Date |
|---|---|---|---|---|
| K173961 | Straumann BLX Implant System | Institut Straumann AG | Substantially Equivalent | 5 Jun 2018 |
| K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments | Institut Straumann AG | Substantially Equivalent | 28 Dec 2018 |
| K191256 | Straumann BLX Ø3.5 mm Implants | Institut Straumann AG | Substantially Equivalent | 27 Dec 2019 |
| K210855 | Straumann BLX Implant System | Institut Straumann AG | Substantially Equivalent | 21 Jun 2021 |
| K212533 | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants | Institut Straumann AG | Substantially Equivalent | 28 Jan 2022 |
| GUDID 07630031743275 | BLX Implant, Ø 3.5mm RB, SLActive® 8mm, Roxolid® | Institut Straumann AG | Premarket submission K191256 | — |
FDA clearance means the FDA found the device substantially equivalent to a legally marketed device. It is not a ranking of quality or clinical results. EU (EUDAMED) records will be added.
Safety notices & recalls
No FDA recall record found.
openFDA recall search “product_description:BLX” run on 27 Sept 2026: 0 result(s). No result is not proof that no recall or field safety notice exists in any market.
Clinical evidence
We have not yet linked any system-specific studies to Straumann BLX. Evidence on materials, connections and loading protocols that applies across systems is in the evidence explorer. We don't quote single-study survival rates as brand scores.
Compare BLX with…
Sources
- Straumann® BLX Implant System — Basic Information (Technical handling information), document 702115 — Institut Straumann AG, 2024-11-20. Accessed 27 Sept 2026.
- FDA 510(k) K173961 — Straumann BLX Implant System (510(k) summary) — U.S. Food and Drug Administration, 2018-06-05. Accessed 27 Sept 2026.
- openFDA Device 510(k) API — U.S. Food and Drug Administration. Accessed 27 Sept 2026.
- AccessGUDID device record 07630031743275 — Straumann BLX Ø3.5 mm Implants — FDA / NLM AccessGUDID. Accessed 27 Sept 2026.
Straumann®, BLX®, Roxolid®, SLActive®, TorcFit™ are trademarks of their respective owner. Found an error? Email info@dentalimplantbrands.com.
Educational information only. Implant-system selection requires assessment by a qualified dental professional.