# K192612: Kerecis Gingiva Graft

- Pathway: 510(k) (Traditional)
- Applicant: Kerecis Limited
- Decided: Nov 13, 2020 after 420 days
- Product code: NPL (Barrier, Animal Source, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K924408 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102531: Mucograft, Ed. Geistlich Soehne AG Fur Chemische Industrie (2010) Summary page 4.

## Indications for use
Kerecis Gingiva Graft is indicated for: – Localized gingival augmentation to increase keratinized tissue (KT) around teeth or implants.

Source page: https://510kreport.com/device/K192612
Methodology: https://510kreport.com/methodology