Cleared Traditional

K212281 - Surgical Trays

K212281 is an FDA 510(k) clearance for Surgical Trays, 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 226-day FDA review.

K212281 · Dentsply Sirona, Inc. · General Hospital
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Mar 2022
Decision
226d
Days
Class 2
Risk

K212281 is an FDA 510(k) clearance for the Surgical Trays. 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 March 4, 2022 after a review of 226 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 - K212281

510(k) Number K212281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 129d · This submission: 226d
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 172
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K212281.
Surgical and Prosthetic Trays
K220791 · Dentsply Sirona · May 2022
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K214051 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · Apr 2022
Southern Implants Instrument Trays
K210923 · Southern Implants (Pty), Ltd. · Mar 2022
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K203177 · O&M Halyard, Inc. · Jan 2022
EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device
K213209 · K1 Medical, LLC · Dec 2021