# K082111: Straumann Membragel

- Pathway: 510(k) (Traditional)
- Applicant: Institut Straumann AG
- Decided: May 22, 2009 after 298 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: 4 generations back to K924408 (1995). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050446: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone, Ed. Geistlich Soehne AG Fuer Chemische Industrie (2005) Summary page 1.
- K982865: Atrisorb Bioabsorbable Guided Tissue Regeneration (GTR) Barrier Kit, Atrix Laboratories, Inc. (1998) Summary page 1.

## Most influential descendants
- K101956: Straumann Membragel (2010), 0 descendants of its own

## Indications for use
Straumann MembraGel is a biodegradable, synthetic, in situ forming hydrogel material. It is infended to aid in the regeneration and integration of oral tissue components in guided bone regeneration procedures. This includes the surgical treatment of peri-implant defects, bone defects, deficient alveolar ridges, and extraction sockets. Because Straumann 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/K082111
Methodology: https://510kreport.com/methodology