# K101453: Vitala Natural Resorbable Collagen Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Obi Biologics, Inc.
- Decided: Jul 21, 2011 after 422 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.
4 later devices descend from it; 1 cites it directly.
0 of 12 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 1.
- K073097: Tutodent Dental Membrane, Tutogen Medical U.S., Inc. (2008) Summary page 1.
- K053260: Ossix -Plus, Colbar Lifescience, Ltd. (2006) Summary page 2.

## Most influential descendants
- K141177: Vitala Porcine Derived Collagen Membrane (2015), 3 descendants of its own
- K173562: Straumann Jason Membrane (2018), 2 descendants of its own
- K242817: Jason membrane (2025), 0 descendants of its own
- K223912: InterCollagen® Guide (2023), 0 descendants of its own

## Indications for use
Vitala Resorbable Natural Collagen Membrane is intended for use during the process of guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable barrier for: * Simultaneous use with 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; * Alveolar ridge preservation consequent to tooth extraction; * Filling of bone defects after root resection, cystectomy, removal of retained teeth; * Over the window in lateral window sinus elevation procedures; * Furcation defects in multi-rooted teeth; * Treatment of recession defects, together with coronally positioned flap; * In implants with vertical bone loss due to infection, only with satisfactory debridement and implant surface disinfection; * Guided bone regeneration in dehiscence defects; and * Guided tissue regeneration in periodontal defects.

Source page: https://510kreport.com/device/K101453
Methodology: https://510kreport.com/methodology