Cleared Traditional

K242023 - Microdent Sterilization Cassette

K242023 is an FDA 510(k) clearance for Microdent Sterilization Cassette, manufactured by Implant Microdent System S.L.U.. The device is a Class 2 General Hospital device with product code KCT cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K242023 · Implant Microdent System S.L.U. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
223d
Days
Class 2
Risk

K242023 is an FDA 510(k) clearance for the Microdent Sterilization Cassette. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Implant Microdent System S.L.U. (Santa Eulalia De Ronçana, ES). The FDA issued a Cleared decision on February 19, 2025 after a review of 223 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 Implant Microdent System S.L.U. devices

FDA 510(k) Submission Details - K242023

510(k) Number K242023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2024
Decision Date February 19, 2025
Days to Decision 223 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
94d slower than avg
Panel avg: 129d · This submission: 223d
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 174
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K242023.
ONE TRAY® Sealed Sterilization Container System
K250029 · Innovative Sterilization Technologies · May 2025
Synthes Graphic Case & Tray System
K241927 · Synthes GmbH · Mar 2025
Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)
K242564 · Prismatik Dentalcraft, Inc. · Mar 2025
NUVENTUS NV.C™ Surgical Cassette and Tray
K243317 · Infinitum Eta, Ltd. · Feb 2025
System 9 Sterile Battery Container
K242834 · Stryker Instruments · Jan 2025
Klockner Kits
K243128 · SOADCO, S.L. · Dec 2024