# K251908: Emanate Tray

- Pathway: 510(k) (Traditional)
- Applicant: Emanate Biomedical
- Decided: Jul 29, 2026 after 404 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: 3 generations back to K810545 (1981). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083516: Periogenix, Oroscience, Inc. (2009) Summary page 5.

## Indications for use
Emanate Tray is a periodontal wound dressing intended to protect injured periodontal tissue post planned non-surgical periodontal procedures by forming a temporary physical barrier to avoid further irritation.

Source page: https://510kreport.com/device/K251908
Methodology: https://510kreport.com/methodology