# K173196: SUNTOUCH Dental Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Huizhou Foryou Medical Devices Co., Ltd.
- Decided: Jan 24, 2018 after 114 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: 1 generation back to K090612 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090612: Benacel, Unicare Biomedical (2009) Summary page 4.

## Indications for use
SUNTOUCH® Dental Dressing is intended for use as a wound dressing in extraction sites, and may be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative and traumatic injuries.

Source page: https://510kreport.com/device/K173196
Methodology: https://510kreport.com/methodology