# K090919: Kensey Nash Fibrillar Collagen Dental Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Kensey Nash Corp.
- Decided: Oct 2, 2009 after 184 days
- Product code: NPL (Barrier, Animal Source, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 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)
- K050446: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone, Ed. Geistlich Soehne AG Fuer Chemische Industrie (2005). Our reading of the summary gave K050466, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Bio-Gide”.
- K062881: Collagen Dental Menbrane - Conformable II, Collagen Matrix, Inc. (2006) Summary page 1.

## Recalls of this device
- Feb 28, 2012 · Not classified · Z-1622-2012: Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in patient infection,
- Feb 28, 2012 · Not classified · Z-1621-2012: Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in patient infection,
- Feb 28, 2012 · Not classified · Z-1623-2012: Recall has been initiated due to concerns regarding the sterility of the product. The firm initiated the recall because of use of inadequately sterilized product might result in patient infection,

## Indications for use
The Kensey Nash Fibrillar Collagen Dental Membrane is indicated for: * Simultaneous use of GBR-membrane and implants. * Augmentation around implants placed in immediate extraction sites. * Augmentation around implants placed in delayed extraction sockets. * Localized ridge augmentation for later implantation. * Alveolar ridge reconstruction for prosthetic treatment. * Filling of bone defects after root resection, cystectomy, removal of retained teeth. * Guided bone regeneration in dehiscence defects. * Guided tissue regeneration procedures in periodontal defects

Source page: https://510kreport.com/device/K090919
Methodology: https://510kreport.com/methodology