Cleared Traditional

Microdent Sterilization Cassette (K242023) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 139
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