# K091192: Kensey Nash P1076 Collagen Dental Membrane, Model 20655-XX

- Pathway: 510(k) (Traditional)
- Applicant: Kensey Nash Corp.
- Decided: Nov 2, 2009 after 193 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). 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.

## Indications for use
The Kensey Nash P1076 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/K091192
Methodology: https://510kreport.com/methodology