# K142496: Collagen Dental Membrane - Conformable IIBP

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Nov 24, 2014 after 80 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: 5 generations back to K924408 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090216: Collagen Dental Membrane IV, Collagen Matrix, Inc. (2009) Summary page 4.
- K073097: Tutodent Dental Membrane, Tutogen Medical U.S., Inc. (2008) Summary page 4.

## Indications for use
Collagen Dental Membrane - Conformable IIBP is intended for use in oral surgical procedures as a resorbable membrane material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.

Source page: https://510kreport.com/device/K142496
Methodology: https://510kreport.com/methodology