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FDA 510(k)

Stainless Steel Surgical Kits

K-Number: K251614 · 2026-02-06

ApplicantDentsply Sirona, Inc.
Decision Date2026-02-06
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Stainless Steel Surgical Kits 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 2026-02-06 under 510(k) number K251614. 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 Stainless Steel Surgical Kits?

Stainless Steel Surgical Kits is a medical device that received FDA 510(k) clearance on 2026-02-06. The listed applicant is Dentsply Sirona, Inc.. The 510(k) number is K251614.

When did Stainless Steel Surgical Kits receive FDA 510(k) clearance?

Stainless Steel Surgical Kits received FDA 510(k) clearance on 2026-02-06, under 510(k) number K251614.

Who is the listed applicant for Stainless Steel Surgical Kits?

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 Stainless Steel Surgical Kits?

The FDA product code for Stainless Steel Surgical Kits is KCT.

Other records listing Dentsply Sirona, Inc. 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.K251756Sterilization TraysParagon Implant Mfg., LLCK251300Plastic Surgical KitsDentsply Sirona, Inc.

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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