# K063812: Straumann Prefgel

- Pathway: 510(k) (Special)
- Applicant: Straumann USA
- Decided: Jan 12, 2007 after 21 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: 1 generation back to K940737 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940737: Edta Gel (TM), Karolinska Institutet (1994) Summary page 1.

## Most influential descendants
- K162311: Straumann PrefGel (2017), 0 descendants of its own

## Indications for use
The Straumann© PrefGelTM is indicated for topical application onto exposed root surfaces during periodontal surgery in order to selectively remove the smear-layer. PrefGel has been shown to produce a fibrillar collagenous meshwork on the exposed and conditioned root surface by selective removal of mineral. It does not induce any detectable necrosis in the surrounding periodontal tissues.

Source page: https://510kreport.com/device/K063812
Methodology: https://510kreport.com/methodology