# K090612: Benacel

- Pathway: 510(k) (Traditional)
- Applicant: Unicare Biomedical
- Decided: Jul 24, 2009 after 140 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SaliCept®: named in the summary without a submission number
- (no number) "Sock It" oral pain gel: named in the summary without a submission number
- (no number) Hemcon®: named in the summary without a submission number

## Most influential descendants
- K173196: SUNTOUCH Dental Dressing (2018), 0 descendants of its own

## Indications for use
Benacel® Dental Dressing is intended for use as a wound dressing in extraction sites and the management of alveolar osteitis (dry socket) and may be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative, donor sites, and traumatic injuries. Benacel® Dental Dressing may also be used as a wound dressing for the management and protection of oral lesions, including sores, ulcers, and injuries, such as cuts, lacerations and abrasions of the oral mucosa.

Source page: https://510kreport.com/device/K090612
Methodology: https://510kreport.com/methodology