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FDA 510(k)

Straumann Surgical Cassettes

K-Number: K203753 · 2021-07-29

ApplicantStraumann USA, LLC
Decision Date2021-07-29
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Straumann Surgical Cassettes is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA, LLC. It received FDA 510(k) clearance on 2021-07-29 under 510(k) number K203753. 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 Surgical Cassettes?

Straumann Surgical Cassettes is a medical device that received FDA 510(k) clearance on 2021-07-29. The listed applicant is Straumann USA, LLC. The 510(k) number is K203753.

When did Straumann Surgical Cassettes receive FDA 510(k) clearance?

Straumann Surgical Cassettes received FDA 510(k) clearance on 2021-07-29, under 510(k) number K203753.

Who is the listed applicant for Straumann Surgical Cassettes?

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

What is the FDA product code for Straumann Surgical Cassettes?

The FDA product code for Straumann Surgical Cassettes is KCT.

Other records listing Straumann USA, LLC 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.

K241575Straumann® Anatomic Healing Abutments XC (AHA)K202942Straumann 4 mm Short ImplantsK192401Straumann Screw-Retained AbutmentsK190662MRI Compatibility for Existing Straumann Dental Implant SystemsK171784Straumann Dental Implant SystemK162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment

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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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