# K251614: Stainless Steel Surgical Kits

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona, Inc.
- Decided: Feb 6, 2026 after 255 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: 11 generations back to K844002 (1984). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220791: Surgical and Prosthetic Trays, Dentsply Sirona (2022) Summary page 6.

## Indications for use
Stainless Steel Surgical Kits •The Stainless Steel Surgical Kits are intended for organizing, sterilizing and storing of drills, instruments, and prosthetic accessories. •The Stainless Steel Surgical Kits are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch. Sterilization parameters •Pre-vacuum Steam at 132 °C (270 °F) for 4 minutes with a 20 minute dry time. •Do not exceed the worst-case validated maximum load:

Source page: https://510kreport.com/device/K251614
Methodology: https://510kreport.com/methodology