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FDA 510(k)

Straumann® ProClean™ Cassette (041.800 ; 041.801)

K-Number: K260726 · 2026-06-03

ApplicantInstitut Straumann AG
Decision Date2026-06-03
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Straumann® ProClean™ Cassette (041.800 ; 041.801) is the device name listed in this FDA 510(k) record. The listed applicant is Institut Straumann AG. It received FDA 510(k) clearance on 2026-06-03 under 510(k) number K260726. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Straumann® ProClean™ Cassette (041.800 ; 041.801)?

Straumann® ProClean™ Cassette (041.800 ; 041.801) is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is Institut Straumann AG. The 510(k) number is K260726.

When did Straumann® ProClean™ Cassette (041.800 ; 041.801) receive FDA 510(k) clearance?

Straumann® ProClean™ Cassette (041.800 ; 041.801) received FDA 510(k) clearance on 2026-06-03, under 510(k) number K260726.

Who is the listed applicant for Straumann® ProClean™ Cassette (041.800 ; 041.801)?

The FDA 510(k) record lists Institut Straumann AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Straumann® ProClean™ Cassette (041.800 ; 041.801)?

The FDA product code for Straumann® ProClean™ Cassette (041.800 ; 041.801) is KCT.

Other records listing Institut Straumann AG as applicant

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Related Devices (Code: KCT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLCK251300Plastic Surgical KitsDentsply Sirona, Inc.

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.

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