# K260726: Straumann® ProClean™ Cassette (041.800 ; 041.801)

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Jun 3, 2026 after 90 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: 10 generations back to K844002 (1984). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191475: Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate, Nobel Biocare AB (2019) Summary page 6.

## Indications for use
The ProClean™ Cassette is indicated to store and organize Straumann® surgical instruments required during dental implant treatment of the Straumann iExcel™ and Straumann iGuide™ surgical procedures. The ProClean™ Cassette is indicated to hold and organize the Straumann® surgical instruments during automated cleaning/thermal disinfection, and sterilization in healthcare facilities by healthcare professionals. The ProClean™ Cassette is only indicated for automated cleaning and thermal disinfection in a washer-disinfector. The ProClean™ Cassette is not indicated to maintain sterility and must be used in conjunction with a legally marketed, validated sterilization pouch or a sterilization container. The Straumann ProClean™ Cassette has been validated for the following maximum load (including instruments and cassette): Max. 1223 grams. Recommended sterilization time (exposure time at the sterilization temperature) and drying time:

Source page: https://510kreport.com/device/K260726
Methodology: https://510kreport.com/methodology