Cleared Traditional

Surgical Trays

K212281 · Dentsply Sirona, Inc. · General Hospital

Mar 2022

Decision

226d

Days

Class 2

Risk

About This 510(k) Submission

K212281 is an FDA 510(k) clearance for the Surgical Trays, 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 March 4, 2022, 226 days after receiving the submission on July 21, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K212281 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 21, 2021
Decision Date	March 04, 2022
Days to Decision	226 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