# K222640: Sweden & Martina Surgical Trays

- Pathway: 510(k) (Traditional)
- Applicant: Sweden & Martina S.P.A.
- Decided: May 26, 2023 after 267 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 TRAYS are 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 Sweden & Martina trays are available in two (2) formats, nominal dimensions Size M (189x140 mm h 61.5 mm) and Size L (270x150 mm h 62 mm), and the worst-case loading configuration have been validated for a maximum load of 740 grams for all device configurations. 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.

Source page: https://510kreport.com/device/K222640
Methodology: https://510kreport.com/methodology