Straumann BLX Implant System
K-Number: K210855 · 2021-06-21
ApplicantInstitut Straumann AG
Decision Date2021-06-21
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 2021-06-21 under approval number K210855. 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 2021-06-21. It is manufactured by Institut Straumann AG. The 510(k) number is K210855.
When was Straumann BLX Implant System approved by the FDA?
Straumann BLX Implant System received FDA 510(k) clearance on 2021-06-21, under approval number K210855.
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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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.