# K241283: Elemental Granulate

- Pathway: 510(k) (Traditional)
- Applicant: Zinkh NV
- Decided: Jan 3, 2025 after 241 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 K881422 (1988). 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)
- K881422: Coe Pak Auto Mix, Regular or Hard Set, Coe Laboratories, Inc. (1988) Summary page 5.

## Indications for use
Elemental Granulate is a periodontal wound dressing intended to protect injured periodontal tissue as surgical sites.

Source page: https://510kreport.com/device/K241283
Methodology: https://510kreport.com/methodology