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FDA 510(k)

Straumann BLX Implant System

K-Number: K173961 · 2018-06-05

ApplicantInstitut Straumann AG
Decision Date2018-06-05
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann BLX Implant System is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2018-06-05 under approval number K173961. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Straumann BLX Implant System?

Straumann BLX Implant System is a medical device that received FDA 510(k) clearance on 2018-06-05. It is manufactured by Institut Straumann AG. The 510(k) number is K173961.

When was Straumann BLX Implant System approved by the FDA?

Straumann BLX Implant System received FDA 510(k) clearance on 2018-06-05, under approval number K173961.

What company makes Straumann BLX Implant System?

Straumann BLX Implant System is manufactured by Institut Straumann AG.

What is the FDA product code for Straumann BLX Implant System?

The FDA product code for Straumann BLX Implant System is DZE.

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Related PubMed Literature

PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025)

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Related Devices (Code: DZE)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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