Institut Straumann AG is one of 92 FDA 510(k) medical device manufacturers from Switzerland in the dataset, ranked by real submission volume.
Institut Straumann AG - FDA 510(k) Cleared Devices
Recent clearances: Straumann® ProClean™ Cassette (041.800, Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue, Straumann® BLC Implants - Indication Widening
Institut Straumann AG has 90 FDA 510(k) cleared dental devices. Based in Basel, CH.
Latest FDA clearance: Jun 2026. Active since 1990.
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510(k) submissions have been managed by Straumann USA, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Institut Straumann AG
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