# K251756: Sterilization Trays

- Pathway: 510(k) (Traditional)
- Applicant: Paragon Implant Mfg., LLC
- Decided: Nov 14, 2025 after 158 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). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202524: Standard Sterilizable Tray, Implant Direct Sybron Manufacturing, LLC (2021) Summary page 5.

## Indications for use
The Sterilization Trays are designed to hold various dental surgical and prosthetic instruments to organize, steam sterilize and transport the instruments between uses. The kit is to be enclosed in an FDA cleared steam sterilizable pouch large enough to fit a tray, and sterilized in an FDA cleared sterilizer for the following cycles: 1. Gravity Steam Cycle — At 132°C for 15 minutes with a 30-minute dry time 2. Pre-vacuum Steam Cycle — At 132°C for 4 minutes with a 20-minute dry time * The kits are intended for sterilization of non-porous loads * The tested kit represents the worst-case validated load of 497.1 grams

Source page: https://510kreport.com/device/K251756
Methodology: https://510kreport.com/methodology