# K160474: DSM Biomedical Porcine Pericardium Dental Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Kensey Nash Corporation Dba Dsm Biomedical
- Decided: Jun 7, 2016 after 109 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: 3 generations back to K924408 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.

## Indications for use
DSM Biomedical Porcine Pericardium Dental Membrane is indicated for: - simultaneous use of GBR-membrane and implants - augmentation around implants placed in immediate extraction sockets - 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/K160474
Methodology: https://510kreport.com/methodology