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FDA 510(k)

SteriBest® Sterilization Tray System

K-Number: K253187 · 2026-06-18

ApplicantMastel Surgical
Decision Date2026-06-18
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SteriBest® Sterilization Tray System is the device name listed in this FDA 510(k) record. The listed applicant is Mastel Surgical. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K253187. 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 SteriBest® Sterilization Tray System?

SteriBest® Sterilization Tray System is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Mastel Surgical. The 510(k) number is K253187.

When did SteriBest® Sterilization Tray System receive FDA 510(k) clearance?

SteriBest® Sterilization Tray System received FDA 510(k) clearance on 2026-06-18, under 510(k) number K253187.

Who is the listed applicant for SteriBest® Sterilization Tray System?

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

What is the FDA product code for SteriBest® Sterilization Tray System?

The FDA product code for SteriBest® Sterilization Tray System is KCT.

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.

K260726Straumann® 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., 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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