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FDA 510(k)

Washtrays

K-Number: K231144 · 2024-01-16

ApplicantDentsply Sirona
Decision Date2024-01-16
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Washtrays is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2024-01-16 under 510(k) number K231144. 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 Washtrays?

Washtrays is a medical device that received FDA 510(k) clearance on 2024-01-16. The listed applicant is Dentsply Sirona. The 510(k) number is K231144.

When did Washtrays receive FDA 510(k) clearance?

Washtrays received FDA 510(k) clearance on 2024-01-16, under 510(k) number K231144.

Who is the listed applicant for Washtrays?

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

What is the FDA product code for Washtrays?

The FDA product code for Washtrays is KCT.

Other records listing Dentsply Sirona as applicant

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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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