# K250512: Augmented Gingival Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.
- Decided: Dec 5, 2025 after 287 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: 10 generations back to K924408 (1995). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210280: Geistlich Mucograft®, Geistlich Mucograft® Seal, Geistlich Pharma AG (2021) Summary page 5.

## Indications for use
It is indicated for localized gingival augmentation to increase keratinized tissue (KT) around teeth.

Source page: https://510kreport.com/device/K250512
Methodology: https://510kreport.com/methodology