# K151344: Cytoflex Tefguard Ti-Enforced Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Unicare Biomedical, Inc.
- Decided: Nov 19, 2015 after 184 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)
- K972278: Cytoplast Regentex Titanium 250, Osteogenics Co. (1997) Summary page 5.
- K143327: Neoss Ti Reinforced Membrane, Neoss, Ltd. (2015) Summary page 5.

## Indications for use
Cytoflex® Tefguard® Ti-Enforced membrane is a temporarily, non-resorbable, implantable material for use as a space-making barrier in the treatment of periodontal defects and augmentation of alveolar ridge in accordance with guided tissue regeneration principle.

Source page: https://510kreport.com/device/K151344
Methodology: https://510kreport.com/methodology