# K213904: Kerecis Oral

- Pathway: 510(k) (Traditional)
- Applicant: Kerecis
- Decided: Sep 30, 2022 after 290 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: 6 generations back to K924408 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073711: Mucograft Collagen Matrix, Ed. Geistlich Soehne AG Fuer Chemische Industrie (2008) Summary page 4.

## Indications for use
• Localized gingival augmentation to increase keratinized tissue (KT) around teeth or implants; • Covering of implants placed in immediate extraction sockets; • Covering of implants placed in delayed extraction sockets; • Covering of bone defects after root resection and removal of retained teeth; and • Guided tissue regeneration procedures in periodontal and recession defects.

Source page: https://510kreport.com/device/K213904
Methodology: https://510kreport.com/methodology