Straumann TLX Implant System
K-Number: K200586 · 2020-08-20
ApplicantInstitut Straumann AG
Decision Date2020-08-20
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Straumann TLX Implant System is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2020-08-20 under approval number K200586. 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 TLX Implant System?
Straumann TLX Implant System is a medical device that received FDA 510(k) clearance on 2020-08-20. It is manufactured by Institut Straumann AG. The 510(k) number is K200586.
When was Straumann TLX Implant System approved by the FDA?
Straumann TLX Implant System received FDA 510(k) clearance on 2020-08-20, under approval number K200586.
What company makes Straumann TLX Implant System?
Straumann TLX Implant System is manufactured by Institut Straumann AG.
What is the FDA product code for Straumann TLX Implant System?
The FDA product code for Straumann TLX 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.