# K210923: Southern Implants Instrument Trays

- Pathway: 510(k) (Traditional)
- Applicant: Southern Implants (Pty), Ltd.
- Decided: Mar 2, 2022 after 338 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: 7 generations back to K844002 (1984). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142519: InterActive Complete Surgical Tray, Implant Direct Sybron Manufacturing, LLC (2015) Summary page 4.

## Indications for use
The Southern Implants Instrument Tray is designed to hold various dental surgical drills and tools 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 and sterilized in an FDA Cleared sterilizer for one of the following cycles: • Pre-vacuum Steam – At 132°C for 4 minutes with a 20 minutes dry time. • Pre-vacuum Steam – At 135°C for 3 minutes with a 20 minutes dry time. The trays are not intended for sterilization of non-porous loads. The trays are recommended not to be stacked during sterilization. The Complete Surgical Trays represent the worst case validated load due to number of components (Large: 25 Medium: 90 and Small: 47 instruments) and the weight (Large: 752; Medium: 672 and Small 339 grams). Southern Implants (Pty.) Ltd. does not make any lumen claims for the Southern Implants Instrument Trays.

Source page: https://510kreport.com/device/K210923
Methodology: https://510kreport.com/methodology