# K252253: Geistlich Mucograft® /Geistlich Mucograft®  Seal; Geistlich Fibro-Gide®

- Pathway: 510(k) (Traditional)
- Applicant: Geistlich Pharma AG
- Decided: Nov 25, 2025 after 127 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). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 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.
- K171050: Geistlich Fibro-Gide, Geistlich Pharma AG (2017) Summary page 7.

## Indications for use
Geistlich Mucograft® and Geistlich Mucograft® Seal are indicated for: * covering of implants placed in immediate or delayed extraction sockets; * localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants; * alveolar ridge reconstruction for prosthetic treatment; and * recession defects for root coverage. Geistlich Fibro-Gide® is intended for soft tissue augmentation. It is indicated for: * recession defects for root coverage. * alveolar ridge reconstruction for prosthetic treatment; and * localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants;

Source page: https://510kreport.com/device/K252253
Methodology: https://510kreport.com/methodology