# K230529: HealiAid Dental Collagen Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Maxigen Biotech, Inc.
- Decided: Nov 22, 2023 after 268 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: 10 generations back to K910944 (1991). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152600: Collagen Dental Wound Dressings, Collagen Matrix, Inc. (2016) Summary page 5.

## Indications for use
HealiAid® Dental Collagen Wound Dressing is indicated for the management of oral wounds and sores, including: 1. Denture sores 2. Oral ulcers (non-infected or viral) 3. Periodontal surgical wounds 4. Extraction sites 5. Surgical wounds. 6. Traumatic wounds

Source page: https://510kreport.com/device/K230529
Methodology: https://510kreport.com/methodology