# K962545: Dental, Medical Instrument Cases & Cassette

- Pathway: 510(k) (Traditional)
- Applicant: Sterilization Cassette Systems, Inc.
- Decided: Mar 7, 1997 after 252 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
No predicates in its family tree.
179 later devices descend from it; 2 cite it directly.
1 of 180 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K980065: C/T Med-Systems Cassette System (1998), 152 descendants of its own
- K990761: Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette (1999), 150 descendants of its own
- K012105: Polyvac Surgical Instrument Delivery System (2002), 149 descendants of its own
- K033222: Olympus Sterilization Trays (2004), 58 descendants of its own
- K040223: Polyvac Instrument Delivery System (2004), 46 descendants of its own

Source page: https://510kreport.com/device/K962545
Methodology: https://510kreport.com/methodology