# K040403: Collagen Wound Dressing - Oral

- Pathway: 510(k) (Traditional)
- Applicant: Collagen Matrix, Inc.
- Decided: May 10, 2004 after 83 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: 2 generations back to K910944 (1991). 6 ancestors in all.
10 later devices descend from it; 4 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)
- K994339: Hycure Oral / Hycure Oral Smart Gel, The Hymed Group Corp. (2000) Summary page 1.
- K030921: Collagen Topical Wound Dressing, Collagen Matrix, Inc. (2003) Summary page 1.

## Most influential descendants
- K110388: Collacare Dental (2011), 6 descendants of its own
- K122115: Collagen Dental Wound Dressings (2012), 5 descendants of its own
- K152600: Collagen Dental Wound Dressings (2016), 2 descendants of its own
- K133290: Collacare Dental (2014), 1 descendant of its own
- K080868: Aongen Collagen Matrix (2009), 1 descendant of its own

## Indications for use
Collagn Wound Dressing - Oral is indicated for the management of oral wounds and sores, including: · Denture sores * Oral ulcers (non-infected or viral) · Periodontal surgical wounds · Suture sites · Bums · Extraction sites · Surgical wounds · Traumatic wounds

Source page: https://510kreport.com/device/K040403
Methodology: https://510kreport.com/methodology