# K242564: Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Mar 21, 2025 after 205 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). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180791: Straumann BLX Surgical Cassette, Institut Straumann AG (2018) Summary page 5.

## Indications for use
The Autoclavable Cassettes are used in healthcare facilities to organize surgical and prosthetic instruments during sterilization, storage, and transport during and after surgical uses. The Autoclavable Cassettes are not intended to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated sterilization wrap to maintain the sterility of the enclosed devices. Sterilization parameters: Pre-vacuum steam: 132°C (270° F) for 4 minutes with 30 minutes drying time. Sterilization validations for the worst-case Autoclavable Cassette included cassette and instruments. The Autoclavable Cassettes are validated for a maximum load of 641 grams for Glidewell HT™ Implant Guided Surgical Kit, 476 grams for Glidewell HT™ Implant Surgical Kit, and 192 grams for Glidewell™ Prosthetic Kit.

Source page: https://510kreport.com/device/K242564
Methodology: https://510kreport.com/methodology