FDA 510(k)

Straumann® ProClean™托盘（041.800；041.801）

K号: K260726 · 2026-06-03

决定日期2026-06-03

产品代码KCT

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Institut Straumann AG为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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