# K112568: Aongen Dental Collagen Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Aeon Astron Europe B.V.
- Decided: Mar 1, 2012 after 177 days
- Product code: OLR (Oral Wound Dressing)
- Device class: U
- 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 K881854 (1988). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073685: Ota Collagen Biomaterial, Osseous Technologies of America (2008) Summary page 1.
- K081635: Integra Meshed Bilayer Wound Matrix, Integra Lifesciences Corp. (2008) Summary page 1.

## Indications for use
AongenTM Dental is intended for use in dental surgical procedures as a resorbable material for open wounds to aid in wound healing post surgery.

Source page: https://510kreport.com/device/K112568
Methodology: https://510kreport.com/methodology