# K123697: Matricel Dental Barrier Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Matricel GmbH
- Decided: Feb 24, 2014 after 448 days
- Product code: NPL (Barrier, Animal Source, 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.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042197: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration, Ed. Geistlich Soehne AG Fuer Chemische Industrie (2004) Summary page 1.
- K050446: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone, Ed. Geistlich Soehne AG Fuer Chemische Industrie (2005) Summary page 1.
- K053260: Ossix -Plus, Colbar Lifescience, Ltd. (2006) Summary page 1.

## Indications for use
The Dental Barrier Membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier membrane for * Ridge augmentation for later implant insertion * Augmentation around implants placed in immediate/delayed extraction sockets * Localized ridge augmentation * Alveolar ridge preservation/reconstruction * Osseous fill around implants in peri-implantitis bone defects * Over the window in lateral window sinus elevation procedures * Intr-bony defects around teeth * Treatment of recession defects, together with coronally positioned flap * In fiarcation defects in multi-rooted teeth.

Source page: https://510kreport.com/device/K123697
Methodology: https://510kreport.com/methodology