# K191566: Avinent Surgical Tray

- Pathway: 510(k) (Traditional)
- Applicant: Avinent Implant System S.L.U.
- Decided: Mar 6, 2020 after 267 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: 7 generations back to K844002 (1984). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142519: InterActive Complete Surgical Tray, Implant Direct Sybron Manufacturing, LLC (2015) Summary page 4.

## Most influential descendants
- K212068: Biotech Dental Kits (2021), 0 descendants of its own
- K201533: Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes (2021), 0 descendants of its own

## Indications for use
The Avinent Surgical Tray is 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 Surgical Tray. -The tray will be marketed in the variations found in the following table.

Source page: https://510kreport.com/device/K191566
Methodology: https://510kreport.com/methodology