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FDA 510(k)

Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes

K-Number: K201533 · 2021-03-01

ApplicantAvinent Implant System S.L.U.
Decision Date2021-03-01
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes is the device name listed in this FDA 510(k) record. The listed applicant is Avinent Implant System S.L.U.. It received FDA 510(k) clearance on 2021-03-01 under 510(k) number K201533. 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 Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes?

Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes is a medical device that received FDA 510(k) clearance on 2021-03-01. The listed applicant is Avinent Implant System S.L.U.. The 510(k) number is K201533.

When did Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes receive FDA 510(k) clearance?

Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes received FDA 510(k) clearance on 2021-03-01, under 510(k) number K201533.

Who is the listed applicant for Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes?

The FDA 510(k) record lists Avinent Implant System S.L.U. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes?

The FDA product code for Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes is KCT.

Other records listing Avinent Implant System S.L.U. 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.

K260527FACE4D AlignerK191566Avinent Surgical Tray

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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