Cleared Traditional

K251614 - Stainless Steel Surgical Kits

K251614 is an FDA 510(k) clearance for Stainless Steel Surgical Kits, manufactured by Dentsply Sirona, Inc.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K251614 · Dentsply Sirona, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2026
Decision
255d
Days
Class 2
Risk

K251614 is an FDA 510(k) clearance for the Stainless Steel Surgical Kits. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on February 6, 2026 after a review of 255 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentsply Sirona, Inc. devices

FDA 510(k) Submission Details - K251614

510(k) Number K251614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2025
Decision Date February 06, 2026
Days to Decision 255 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 129d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KCT Device Classification - Class 2, Special Controls

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 230
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K251614.
SteriTite Container System with MediTray Products
K252854 · Case Medical, Inc. · Jun 2026
Straumann® ProClean™ Cassette (041.800
K260726 · Institut Straumann AG · Jun 2026
PUREVUE™ Quick Connect Cannula System Tray
K253791 · DePuy Mitek, Inc. · Feb 2026
Sterilization Trays
K251756 · Paragon Implant Mfg., LLC · Nov 2025
Guided DAS Surgical Kit
K243425 · Talladium Espa?a, SL · Jul 2025
Plastic Surgical Kits
K251300 · Dentsply Sirona, Inc. · Jul 2025