510(k) K242023

Microdent Sterilization Cassette by Implant Microdent System S.L.U. — Product Code KCT

K242023 is an FDA 510(k) premarket notification submitted by Implant Microdent System S.L.U. for the device "Microdent Sterilization Cassette". The FDA issued a decision of Substantially Equivalent on February 19, 2025. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2025
Date Received
July 11, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type