# K242023: Microdent Sterilization Cassette

- Pathway: 510(k) (Traditional)
- Applicant: Implant Microdent System S.L.U.
- Decided: Feb 19, 2025 after 223 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K844002 (1984). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012105: Polyvac Surgical Instrument Delivery System, Symmetry Medical, Inc. (2002) Summary page 6.

## Indications for use
Microdent Sterilization Cassette is intended to organize, protect, and store various dental surgical drills and tools in order to organize and facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with FDA-cleared sterilization accessories (wrap, biological indicators, and chemical indicators) in an FDA-cleared sterilizer, sterility of the enclosed medical devices is maintained until used. The sterilization cassette is intended for sterilization in a pre-vacuum steam sterilizer utilizing this recommended cycle: - Temperature: 270 0 F/1320 C - Exposure time: 4 minutes. - Drying time: 20 minutes. - The cassettes are not to be stacked during sterilization. - KTF and KBE references represent the worst case/best case validated load due to the total weight of 509 grams and 220 grams respectively. - Implant Microdent System S.L. does not make any lumen claims for the Microdent Sterilization Cassette. The following list of sterilization cassette models are available and the corresponding instrument load weight that can be sterilized in each model is as listed.

Source page: https://510kreport.com/device/K242023
Methodology: https://510kreport.com/methodology