# K152600: Collagen Dental Wound Dressings

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: Jun 23, 2016 after 286 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K910944 (1991). 14 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122115: Collagen Dental Wound Dressings, Collagen Matrix, Inc. (2012) Summary page 4.

## Most influential descendants
- K243071: Bovine Dermis Collagen Dermal Matrix (2024), 0 descendants of its own
- K230529: HealiAid Dental Collagen Wound Dressing (2023), 0 descendants of its own

## Recalls of this device
- Aug 3, 2022 · Class II · Z-1777-2022: The packaging may not be sealed, which could compromise sterility.

## Indications for use
Collagen Dental Wound Dressings are indicated 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/K152600
Methodology: https://510kreport.com/methodology