Straumann BLC Implants - Indication Widening
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252168 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Straumann BLC Implants are solid, screw-type endosseous dental implants designed for bone-level indications. Constructed from a titanium-13 zirconium alloy (Roxolid), these implants feature a large-grit sandblasted and acid-etched surface, providing enhanced osseointegration and stability for dental restoration.
Intended for surgical placement in the pterygoid region of the maxilla, these implants support multi-unit, splinted prosthetic restorations in posterior regions. Supplied as single-use devices, they are regulated under FDA 510(k) clearance (K252168) and comply with MDR standards. Sterility and sizing are manufacturer-specified for clinical use, with no additional MRI safety considerations stated.
Frequently asked questions
What specific part of the jaw are these implants designed for, and what type of restorations do they support?
The Straumann® BLC Implants are specifically designed for surgical placement in the pterygoid region of the maxilla, which is the upper jaw near the cheekbone. They are intended to support multi-unit, splinted prosthetic restorations in posterior (back) regions of the mouth, providing stability for dental bridges or fixed prosthetics.
Are these implants reusable, or are they meant for single-use only? How does this affect clinical workflow?
The Straumann® BLC Implants are supplied as single-use devices, meaning each implant is intended for one surgical procedure only. This design choice helps ensure sterility and reduces the risk of cross-contamination, simplifying clinical workflow by eliminating the need for cleaning or reprocessing between patients.
What material are these implants made from, and how does that influence their performance?
These implants are constructed from a titanium-13 zirconium alloy (Roxolid), which provides a balance of strength and lightweight properties. The alloy’s composition, combined with a large-grit sandblasted and acid-etched surface, enhances osseointegration—the natural bonding between bone and the implant—while improving stability for long-term dental restorations.
Do these implants require any special handling or storage conditions, particularly regarding sterility?
Since the Straumann® BLC Implants are sterile and single-use, they must be stored according to the manufacturer’s specifications to maintain sterility. This typically includes keeping them in sealed packaging until use and avoiding exposure to moisture, extreme temperatures, or contamination. Always follow the provided instructions to ensure optimal performance and compliance with clinical protocols.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Herzlich willkommen bei Straumann, Straumann BLC™ Implant System, Straumann® BLC Implants - Indication Widening (K252168) — FDA 510 (k ..., Welcome to Straumann, PDF Institut Straumann AG ℅ Jennifer Jackson Senior Director of Regulatory ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K252168 | Class II | Active |
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Manufacturer
- Manufacturer
- Institut Straumann AG
Sources (2)
- FDA 510(k) K252168 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026