# K212281: Surgical Trays

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona, Inc.
- Decided: Mar 4, 2022 after 226 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: 9 generations back to K844002 (1984). 15 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180791: Straumann BLX Surgical Cassette, Institut Straumann AG (2018) Summary page 4.

## Most influential descendants
- K220791: Surgical and Prosthetic Trays (2022), 2 descendants of its own
- K223672: Instrument Case P1340904 (2023), 1 descendant of its own
- K261935: Surgical and Prosthetic Trays (2026), 0 descendants of its own
- K251614: Stainless Steel Surgical Kits (2026), 0 descendants of its own
- K231604: Instrument Case (2023), 0 descendants of its own

## Indications for use
The Surgical Trays are intended for organizing, sterilizing and storing of instruments. The Surgical Trays 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 min with a 20 minutes dry time The tested Surgical Tray represents the worst-case validated load of 513.7g. Do not exceed the following maximum load: Product name Article Max Load (g) Vent to Volume Number Ratio (in-1) OmniTaper Surgical Tray 68015282 513.7 0.033 PrimeTaper Surgical Tray 68015321 513.7 0.033

Source page: https://510kreport.com/device/K212281
Methodology: https://510kreport.com/methodology