# K100695: Colladental Barrier

- Pathway: 510(k) (Traditional)
- Applicant: Collamatrix, Inc.
- Decided: Jan 3, 2013 after 1,029 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.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992216: Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen Menbrane, Integra Lifesciences Corp. (1999) Summary page 2.
- K042197: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration, Ed. Geistlich Soehne AG Fuer Chemische Industrie (2004) Summary page 2.

## Most influential descendants
- K133507: Guidoss (2014), 0 descendants of its own

## Indications for use
CollaDental Barrier is intended for use in oral surgical procedures including use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; filling of bone defects after roots resection, cystectomy, removal of retained teeth; guided bone regeneration in dental implant associated bony dehiscence defects and guided tissue regeneration procedures in bony dehiscence defects around teeth.

Source page: https://510kreport.com/device/K100695
Methodology: https://510kreport.com/methodology