# K094026: Steri-Dent, Steri-Sure

- Pathway: 510(k) (Traditional)
- Applicant: Cpac, Inc.
- Decided: Jul 12, 2011 after 559 days
- Product code: KMH (Sterilizer, Dry Heat)
- Device class: 2
- Regulation: 21 CFR 880.6870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K771070 (1977). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K771070: Dry Heat Sterilizer, Cpac, Inc. (1977) Summary page 2.

## Indications for use
The Model 2100 and 3100 are table-top natural convective (static air type) dry heat sterilizers designed for use in healthcare facilities for the sterilization of wrapped and unwrapped metal instruments. The single sterilization cycle runs at 160°C (320°F) for 1 hour (60 minutes). The Model 2100 and 3100 are identical in operation and only differ in instrument capacity. The Model 2100 is provided with two (2) trays and the Model 3100 is provided with three (3) trays that are slightly larger in size than the Model 2100 trays. The maximum recommended load for each tray for the Model 2100 is 1.3 lbs including the weight of the tray. For the Model 3100, the maximum recommended load for each tray is 1.4 lbs including the weight of the tray.

Source page: https://510kreport.com/device/K094026
Methodology: https://510kreport.com/methodology