Straumann BLC and TLC Implants
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K234049 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 designed for osseointegrated replacement of missing teeth. These implants are categorized under dental implant systems, featuring customised designs for bone-level (BLC) and tissue-level (TLC) applications to support restorative procedures in oral and maxillofacial surgery.
These implants are supplied sterile and intended for single-use in clinical settings. They are authorised under FDA 510(k) clearance (K234049) and comply with the Medical Device Regulation (MDR). The devices are distributed by Institut Straumann AG, Basel, Switzerland, and are classified under the product code DZE for dental advisory committee review.
Frequently asked questions
What types of dental procedures are these implants specifically designed for, and how do their designs differ between BLC and TLC?
The Straumann BLC and TLC Implants are designed for osseointegrated replacement of missing teeth in oral and maxillofacial surgery. The BLC (Bone-Level) implants are tailored for procedures where the implant-abutment interface is submerged below the gum line, promoting bone integration directly around the implant. The TLC (Tissue-Level) implants, in contrast, have a platform designed to sit above the gum tissue, allowing for easier soft-tissue management and restorative procedures where the abutment connects above the gingiva.
Are these implants intended for reuse in clinical settings, and if not, what does the single-use requirement mean for inventory management?
No, these implants are explicitly sterile and intended for single-use only in clinical settings. This means each implant is packaged for one-time surgical use, ensuring patient safety and reducing the risk of cross-contamination. Clinicians should plan inventory accordingly, accounting for the number of procedures scheduled and avoiding reuse to comply with manufacturer guidelines and maintain sterility.
How should these implants be stored to preserve their sterility and performance before use?
Since these implants are supplied sterile, they must be stored in their original, unopened packaging to maintain sterility. The packaging should be kept in a clean, dry environment, protected from direct sunlight, extreme temperatures, and physical damage. Follow the manufacturer’s instructions for storage conditions, typically outlined in the accompanying documentation, to ensure optimal performance and compliance with regulatory requirements.
What regulatory pathways have these implants undergone, and how does that affect their use in the U.S. and Europe?
The Straumann BLC and TLC Implants have undergone FDA 510(k) clearance (K234049) under the Traditional pathway, with a decision of Substantially Equivalent (SESE) to a predicate device, and comply with the Medical Device Regulation (MDR) in Europe. In the U.S., this clearance confirms their safety and effectiveness for their intended use as dental implants, while MDR compliance in Europe ensures they meet stringent EU regulatory standards for market placement. Both pathways validate their suitability for clinical use in their respective regions.
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, Welcome to Straumann, Straumann - Wikipedia, Dashboard | Straumann, Straumann® eShop – Klicken. Finden. Lächeln.
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 | K234049 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Institut Straumann AG
Sources (2)
- FDA 510(k) K234049 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 25, 2026