# K141909: Collagen Dental Membrane - Conformable PP

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Nov 5, 2014 after 113 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: 6 generations back to K924408 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 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 4.
- K100156: Collagen Dental Membrane V, Collagen Matrix, Inc. (2010) Summary page 4.

## Indications for use
Collagen Dental Membrane - Conformable PP is intended for use in oral surgical procedures as a resorbable membrane material for use in: Simultaneous use of GBR-membrane and implants Augmentation around implants placed in immediate extraction sockets Augmentation around implants in delayed extraction sockets Localized ridge augmentation for later implantation Alveolar ridge reconstruction for prosthetic treatment Filling of bone defects after root resection, cystectomy or removal of retained teeth Guided bone regeneration in dehiscence defects and Guided tissue regeneration procedures in periodontal defects.

Source page: https://510kreport.com/device/K141909
Methodology: https://510kreport.com/methodology