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Straumann BLX Temporary Abutment VITA CAD-Temp PMMA

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K220751

by Institut Straumann AG

Identifiers

510(k) Number
K220751 FDA 510(k)
FDA Product Code
NHA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3630 FDA 510(k)
Regulation Number
872.3630 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Straumann BLX Temporary Abutment VITA CAD-Temp PMMA is a dental implant component classified as a Temporary Dental Abutment under the FDA’s dental product category. It is designed as a provisional restoration component for dental implants, providing a stable interface between the implant fixture and the final prosthetic crown or bridge during the healing phase.

This device is supplied as a single-use, non-sterile item and requires sterilization prior to use. It is intended for use in dental offices and oral surgery settings, with dimensions and materials tailored for compatibility with Straumann BLX implant systems. Authorized under FDA 510(k) clearance (K220751) and MDR compliance, it adheres to dental implant standards for temporary abutment applications.

Frequently asked questions

Is this temporary abutment intended for reuse after sterilization, or is it designed as a single-use item regardless of sterilization?

This device is explicitly labeled as a single-use item, even though it requires sterilization before use. The manufacturer’s instructions emphasize that it is not meant to be reused after sterilization, despite its non-sterile supply status. Clinicians should follow sterilization protocols per dental office standards but treat it as disposable after one use.

What types of dental settings or procedures is this abutment specifically designed to support during the healing phase?

The Straumann BLX Temporary Abutment is designed for dental offices and oral surgery settings as a provisional restoration component. It creates a stable interface between the Straumann BLX implant fixture and the final prosthetic crown or bridge during the healing phase of dental implant integration, ensuring stability while osseointegration occurs.

How does the sterility status of this abutment affect its handling and preparation before use in a clinical setting?

The abutment is supplied non-sterile, so it must undergo sterilization prior to use in a clinical setting. Clinicians should follow standard dental sterilization protocols (e.g., autoclave or chemical sterilization) to ensure safety before attaching it to an implant fixture. The manufacturer does not specify sterilization methods, so local office procedures should be consulted.

Are there specific dimensions or material compatibility considerations when using this abutment with Straumann BLX implants?

The abutment is materially and dimensionally tailored for compatibility with Straumann BLX implant systems, though exact measurements or material specifications (e.g., PMMA composition) are not detailed in the provided data. It is designed as a provisional component, so its fit and function rely on the existing BLX implant infrastructure. Always verify fitment with the implant system in use.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Institut Straumann AG

Sources (2)

  • FDA 510(k) K220751 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026