# K202524: Standard Sterilizable Tray

- Pathway: 510(k) (Traditional)
- Applicant: Implant Direct Sybron Manufacturing, LLC
- Decided: Jan 28, 2021 after 149 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: 8 generations back to K844002 (1984). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200858: Mini Sterilizable Tray, Implant Direct Sybron Manufacturing, LLC (2020) Summary page 5.

## Most influential descendants
- K253988: LiteSet Trays (2026), 0 descendants of its own
- K251756: Sterilization Trays (2025), 0 descendants of its own

## Indications for use
The Standard Sterilizable Tray is designed to hold various dental surgical and prosthetic instruments in order to organize, steam sterilize, and transport the instruments between uses. The tray is to be enclosed in an FDA cleared steam sterilizable wrap (maximum thickness KC300) and sterilized in an FDA cleared sterilizer for one of the following cycles: (1) Prevacuum Steam – At 132°C for 4 minutes with a 20 minutes dry time. (2) Gravity Steam – At 132°C for 15 minutes with a 30 minutes dry time. - The tray is intended for sterilization of non-porous loads. - Do not stack trays during sterilization. - The tested Tray represents the worst case validated load of 667.52 grams. - Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Standard Sterilizable Tray.

Source page: https://510kreport.com/device/K202524
Methodology: https://510kreport.com/methodology