# K231144: Washtrays

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Jan 16, 2024 after 270 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)
- K212932: Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray, Nobel Biocare Services AG (2021) Summary page 4.

## Indications for use
Washtrays are intended for organizing, cleaning, sterilizing and storing of instruments. The Washtrays are not intended to maintain sterility and are to be used in conjunction with a legally marketed, validated sterilization pouch or a sterilization container. 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: Product name Article Dimensions Maximum Load Vent to Volume Ratio Number Length x (g) (in-1) Width x Height (in) OmniTaper Washtray 68015271 1107.3 2.54 OmniTaper Washtray GS 68015354 1107.3 2.54 10.83 PrimeTaper Washtray 68015323 X 1107.3 2.54 6.93 1107.3 PrimeTaper Washtray GS 68017267 X 2.54 Washtray 2.32 1107.3 31071000 2.54 Astra Tech Implant System EV Washtray 1107.3 31071020 2.54 GS Astra Tech Implant System EV Ankylos Washtray 31036600 1107.3 2.54

Source page: https://510kreport.com/device/K231144
Methodology: https://510kreport.com/methodology