Straumann SLActive labeling changes
K-Number: K223083 · 2023-06-22
ApplicantInstitut Straumann AG
Decision Date2023-06-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Straumann SLActive labeling changes is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2023-06-22 under approval number K223083. 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 SLActive labeling changes?
Straumann SLActive labeling changes is a medical device that received FDA 510(k) clearance on 2023-06-22. It is manufactured by Institut Straumann AG. The 510(k) number is K223083.
When was Straumann SLActive labeling changes approved by the FDA?
Straumann SLActive labeling changes received FDA 510(k) clearance on 2023-06-22, under approval number K223083.
What company makes Straumann SLActive labeling changes?
Straumann SLActive labeling changes is manufactured by Institut Straumann AG.
What is the FDA product code for Straumann SLActive labeling changes?
The FDA product code for Straumann SLActive labeling changes 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.