# K201533: Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes

- Pathway: 510(k) (Traditional)
- Applicant: Avinent Implant System S.L.U.
- Decided: Mar 1, 2021 after 266 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: 8 generations back to K844002 (1984). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191566: Avinent Surgical Tray, Avinent Implant System S.L.U. (2020) Summary page 4.

## Indications for use
Avinent Sterilization Cassettes are designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap and sterilized in an FDA cleared sterilizer for the following cycle: Prevaccum Steam - At 132° for 4 minutes with a 30 minute dry time. -The trays are intended for sterilization of non-porous loads. -The trays are recommended not to be stacked during sterilization. -The Biomimetic Coral Sterilization Cassette Guided Surgery represents the worst case validated load due to the number of components (32 instruments) and the weight of 599.6 grams. -Avinent Implant System SLU does not make any lumen claims for the Avinent Sterilization Cassettes. -The tray will be marketed in the following variations, Device Model Name Max No. of Instruments Weight of tray full (g) Weight of tray empty (9g) Biomimetic Coral 30 5934 5100 Sterilization Cassette Biomimetic 26 567.8 510.0 Ocean-Iceberg Sterihzation Cassette

Source page: https://510kreport.com/device/K201533
Methodology: https://510kreport.com/methodology