# K121310: Mesothelium Dental Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Kensey Nash Corporation
- Decided: Jul 11, 2013 after 436 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)
- K050446: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone, Ed. Geistlich Soehne AG Fuer Chemische Industrie (2005) Summary page 2.
- K073097: Tutodent Dental Membrane, Tutogen Medical U.S., Inc. (2008) Summary page 2.

## Indications for use
Mesothelium 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 and guided tissue regeneration procedures in periodontal defects. The device is intended for one time use.

Source page: https://510kreport.com/device/K121310
Methodology: https://510kreport.com/methodology