# K122115: Collagen Dental Wound Dressings

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Nov 1, 2012 after 107 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- 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: 8 generations back to K910944 (1991). 13 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110388: Collacare Dental, Innocoll Pharmaceuticals, Ltd. (2011) Summary page 1.
- K040403: Collagen Wound Dressing - Oral, Collagen Matrix, Inc. (2004) Summary page 1.

## Most influential descendants
- K152600: Collagen Dental Wound Dressings (2016), 2 descendants of its own
- K133290: Collacare Dental (2014), 1 descendant of its own
- K253758: Dental Cone; Dental Sponge (2025), 0 descendants of its own
- K243071: Bovine Dermis Collagen Dermal Matrix (2024), 0 descendants of its own
- K230529: HealiAid Dental Collagen Wound Dressing (2023), 0 descendants of its own

## Indications for use
Collagen Dental Wound Dressings are intended for the management of oral wounds and sores, including: Denture sores Oral ulcers (non-infected or viral) Periodontal surgical wounds Suture sites Burns Extraction sites Surgical wounds Traumatic wounds

Source page: https://510kreport.com/device/K122115
Methodology: https://510kreport.com/methodology