# K960292: Gore-Tex Regenerative Material Titanium Reinforced Configurations

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Apr 15, 1996 after 84 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
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GORE-TEX Periodontal Material -- Titanium Reinforced Configurations: named in the summary without a submission number

## Most influential descendants
- K972278: Cytoplast Regentex Titanium 250 (1997), 7 descendants of its own
- K143327: Neoss Ti Reinforced Membrane (2015), 2 descendants of its own
- K201187: Cytoplast Titanium-Reinforced PTFE Membranes (2021), 1 descendant of its own
- K091120: Medpor Contain Implant (2010), 1 descendant of its own
- K221851: Lumina-PTFE Titanium (2023), 0 descendants of its own

## Indications for use
GORE-TEX Regenerative Material is intended to provide a mechanism for the ingrowth of new hard and soft tissues into bony defects surrounding teeth and to augment ingrowth of hard and soft tissues on alveolar ridges. GORE-TEX Regenerative Material is a passive, non-load bearing material. Itis NOT intended for use in load bearing, articulating situations such as temporal mandibular joint reconstruction.

Source page: https://510kreport.com/device/K960292
Methodology: https://510kreport.com/methodology