# K221851: Lumina-PTFE Titanium

- Pathway: 510(k) (Traditional)
- Applicant: Criteria Industria E Comercio DE Produtos Medicinais
- Decided: Dec 8, 2023 after 529 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201187: Cytoplast Titanium-Reinforced PTFE Membranes, Osteogenics Biomedical, Inc. (2021) Summary page 6.

## Indications for use
Lumina-PTFE Titanium is a temporarily implantable material (non-resorbable) indicated for use as a space‐making barrier in the treatment of alveolar and periodontal bony defect sites.

Source page: https://510kreport.com/device/K221851
Methodology: https://510kreport.com/methodology