Cleared Traditional

Stainless Steel Surgical Kits

K251614 · Dentsply Sirona, Inc. · General Hospital

Feb 2026

Decision

255d

Days

Class 2

Risk

About This 510(k) Submission

K251614 is an FDA 510(k) clearance for the Stainless Steel Surgical Kits, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Dentsply Sirona, Inc. (York, US). The FDA issued a Cleared decision on February 6, 2026, 255 days after receiving the submission on May 27, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K251614 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.6850