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FDA 510(k)

Straumann Modular Cassette

K-Number: K191522 · 2019-12-03

ApplicantInstitut Straumann AG
Decision Date2019-12-03
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Straumann Modular Cassette 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 2019-12-03 under 510(k) number K191522. 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 Modular Cassette?

Straumann Modular Cassette is a medical device that received FDA 510(k) clearance on 2019-12-03. The listed applicant is Institut Straumann AG. The 510(k) number is K191522.

When did Straumann Modular Cassette receive FDA 510(k) clearance?

Straumann Modular Cassette received FDA 510(k) clearance on 2019-12-03, under 510(k) number K191522.

Who is the listed applicant for Straumann Modular Cassette?

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 Modular Cassette?

The FDA product code for Straumann Modular Cassette is KCT.

Other records listing Institut Straumann AG as applicant

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.

K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueK252168Straumann® BLC Implants - Indication WideningK253315Straumann Variobase Abutments XC for Bridge/BarK250294Straumann® RidgeFit ImplantsK243278Custom Abutments

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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 SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite 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., LLC

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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