Straumann® ProClean Cassette (041.800; 041.801)— 510(k) K260726

Name: FDA 510(k) clearance K260726
Creator: U.S. Food and Drug Administration
Published: 2026-06-03

Substantially Equivalent

Institut Straumann AG

FDA 510(k) clearance K260726 for Straumann® ProClean Cassette (041.800; 041.801), Substantially Equivalent on 2026-06-03. Applicant: Institut Straumann AG. Device class: 2.

Clearance details

Device name as filed: Straumann® ProClean Cassette (041.800 ; 041.801)
Applicant: Institut Straumann AG
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2026-03-05
Decision date: 2026-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basel, CH

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.