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FDA 510(k)

Standard Sterilizable Tray

K-Number: K202524 · 2021-01-28

ApplicantImplant Direct Sybron Manufacturing, LLC
Decision Date2021-01-28
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Standard Sterilizable Tray is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2021-01-28 under 510(k) number K202524. 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 Standard Sterilizable Tray?

Standard Sterilizable Tray is a medical device that received FDA 510(k) clearance on 2021-01-28. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K202524.

When did Standard Sterilizable Tray receive FDA 510(k) clearance?

Standard Sterilizable Tray received FDA 510(k) clearance on 2021-01-28, under 510(k) number K202524.

Who is the listed applicant for Standard Sterilizable Tray?

The FDA 510(k) record lists Implant Direct Sybron Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Standard Sterilizable Tray?

The FDA product code for Standard Sterilizable Tray is KCT.

Other records listing Implant Direct Sybron Manufacturing, 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.

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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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