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FDA 510(k)

Surgical Trays

K-Number: K212281 · 2022-03-04

ApplicantDentsply Sirona, Inc.
Decision Date2022-03-04
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Surgical Trays is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2022-03-04 under 510(k) number K212281. 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 Surgical Trays?

Surgical Trays is a medical device that received FDA 510(k) clearance on 2022-03-04. The listed applicant is Dentsply Sirona, Inc.. The 510(k) number is K212281.

When did Surgical Trays receive FDA 510(k) clearance?

Surgical Trays received FDA 510(k) clearance on 2022-03-04, under 510(k) number K212281.

Who is the listed applicant for Surgical Trays?

The FDA 510(k) record lists Dentsply Sirona, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Trays?

The FDA product code for Surgical Trays is KCT.

Other records listing Dentsply Sirona, Inc. 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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