# K994339: Hycure Oral / Hycure Oral Smart Gel

- Pathway: 510(k) (Traditional)
- Applicant: The Hymed Group Corp.
- Decided: Mar 22, 2000 after 90 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
No predicates in its family tree.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K040403: Collagen Wound Dressing - Oral (2004), 10 descendants of its own
- 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

## Indications for use
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/K994339
Methodology: https://510kreport.com/methodology