Straumann BLC and TLC Implants
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230108 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 and TLC Implants are dental implants classified under the product code DZE, designed for osseointegration in the jawbone. These implants feature a combination of Roxolid high-performance material and SLActive surface technology, providing enhanced stability and integration in compromised bone conditions.
These implants are supplied sterile and intended for single-use in dental procedures. They are authorized under FDA 510K clearance (K230108) and comply with the Medical Device Regulation (MDR). The devices are intended for use in clinical settings by trained dental professionals, with specific model and size references required for identification.
Frequently asked questions
What materials and technologies are used in the Straumann BLC and TLC Implants to improve integration in the jawbone?
The Straumann BLC and TLC Implants combine Roxolid, a high-performance titanium-zirconium alloy, with SLActive surface technology to enhance osseointegration. Roxolid provides superior strength and stability, while SLActive promotes faster and more reliable bone integration, particularly in compromised or low-density bone conditions.
Are these implants reusable, or are they intended for single-use only?
These implants are explicitly designed for single-use only in dental procedures. The manufacturer supplies them sterile, ensuring patient safety and compliance with clinical best practices for implant placement.
How do I identify the correct model and size for a patient’s specific dental implant procedure?
The Straumann BLC and TLC Implants come in specific model and size references to match the patient’s anatomical requirements. These details are critical for proper placement and should be selected based on the clinician’s assessment of the jawbone structure and treatment plan.
What regulatory pathways have been followed for these dental implants?
The Straumann BLC and TLC Implants have undergone FDA 510(k) clearance (K230108) under the Traditional pathway, with a decision of Substantially Equivalent (SESE) by the Dental Advisory Committee (DE). They also comply with the Medical Device Regulation (MDR), ensuring adherence to both U.S. and EU regulatory standards.
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, Welcome to Straumann, Straumann® Product Catalog 2024 - Institut Straumann - PDF Catalogs ..., PDF STRAUMANN® BLC IMPLANT SYSTEM - schmidt-dental.pl
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 | K230108 | Class II | Active |
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Manufacturer
- Manufacturer
- Institut Straumann AG
Sources (2)
- FDA 510(k) K230108 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026