# K101956: Straumann Membragel

- Pathway: 510(k) (Traditional)
- Applicant: Straumann USA (On Behalf of Institut Straumann Ag)
- Decided: Dec 16, 2010 after 157 days
- Product code: NPK (Barrier, Synthetic, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K924408 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082111: Straumann Membragel, Institut Straumann AG (2009) Summary page 1.

## Indications for use
Straumann MembraGel is a biodegradable, synthetic, in situ forming hydrogel material. It is intended to aid in the regeneration and integration of oral tissue components in guided bone regeneration procedures. This includes the surgical treatment of peni-implant defects, bone defects, deficient alveolar ridges, and extraction sockets. Because MembraGel is not self-supporting, it must be used in combination with a bone graft material in order to maintain space under the membrane.

Source page: https://510kreport.com/device/K101956
Methodology: https://510kreport.com/methodology