Cleared Traditional

Plastic Surgical Kits

K251300 · Dentsply Sirona, Inc. · General Hospital

Jul 2025

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K251300 is an FDA 510(k) clearance for the Plastic 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 July 22, 2025, 85 days after receiving the submission on April 28, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K251300 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 28, 2025
Decision Date	July 22, 2025
Days to Decision	85 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