# K162311: Straumann PrefGel

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: Mar 7, 2017 after 201 days
- Product code: KJJ (Cleanser, Root Canal)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K940737 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063812: Straumann Prefgel, Straumann USA (2007) Summary page 4.

## Indications for use
Straumann PrefGel is intended for topical application onto exposed root surfaces during periodontal surgery in order to remove the smear layer.

Source page: https://510kreport.com/device/K162311
Methodology: https://510kreport.com/methodology