# K220791: Surgical and Prosthetic Trays

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: May 3, 2022 after 46 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: 10 generations back to K844002 (1984). 16 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212281: Surgical Trays, Dentsply Sirona, Inc. (2022) Summary page 4.

## Most influential descendants
- K261935: Surgical and Prosthetic Trays (2026), 0 descendants of its own
- K251614: Stainless Steel Surgical Kits (2026), 0 descendants of its own

## Indications for use
The Surgical and Prosthetic Trays are intended for organizing, sterilizing and storing of instruments. The Surgical and Prosthetic Trays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch.

Source page: https://510kreport.com/device/K220791
Methodology: https://510kreport.com/methodology
