# K182084: Sweden & Martina Surgical Tray (Model ZSHORTY-INT)

- Pathway: 510(k) (Traditional)
- Applicant: Sweden & Martina S.P.A.
- Decided: Nov 4, 2020 after 825 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
SWEDEN & MARTINA SURGICAL TRAY (Model "ZSHORTY-INT") is designed to hold various dental surgical drills and tools in order to organize, steam sterilize, and transport the instruments between uses. Soiled-used tools should never be placed back into the tray or silicone grommets. The tray is to be enclosed in an FDA cleared steam sterilizable wrap, sterilization validation was completed by: - Method Autoclave (Pre-vacuum Dynamic-Air-Removal Cycles) at a temperature of 134 °C (273 °F) with an exposure of four (4) minutes and a minimum drying time of twenty (20) minutes. The validated load weight is 230 grams.

Source page: https://510kreport.com/device/K182084
Methodology: https://510kreport.com/methodology