# K110867: Steri-Dent, Steri-Sure

- Pathway: 510(k) (Traditional)
- Applicant: Cpac, Inc.
- Decided: Jul 20, 2011 after 113 days
- Product code: FRG (Wrap, Sterilization)
- 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: 3 generations back to K990567 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051242: Winner Self Seal Sterilization Pouch, Winner Medical (Usa), Inc. (2005) Summary page 2.

## Indications for use
The Steri-Dent / Steri-Sure Self-Seal Nylon Pouch is intended to be used to allow sterilization of enclosed medical instruments by a dry heat sterilizer operating at 160°C (320°F) for 1 hour (60 minutes) and also to maintain the sterility of the enclosed instruments for 30 days after sterilization.

Source page: https://510kreport.com/device/K110867
Methodology: https://510kreport.com/methodology