# K222549: OpenTex

- Pathway: 510(k) (Traditional)
- Applicant: Purgo Biologics, Inc.
- Decided: May 11, 2023 after 261 days
- Product code: NPK (Barrier, Synthetic, 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: 4 generations back to K922627 (1994). 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)
- K160493: Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm, Salvin Dental Specialties (2016) Summary page 4.

## Indications for use
OpenTex is a temporarily implantable material (non-resorbable) for as a space-making barrier in the treatment of periodontal defects.

Source page: https://510kreport.com/device/K222549
Methodology: https://510kreport.com/methodology