510(k) · Cleared
ClearedGore-Tex Regenerative Material Titanium Reinforced Configurations
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · NPK Barrier, Synthetic, Intraoral
Cleared on Apr 15, 1996 after an 84-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Apr 15, 1996
- Review
- 84 days
- Class
- Class II
- Product code
- NPK
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK960292 Gore-Tex Regenerative Material Titanium Reinforced ConfigurationsW. L. Gore & Associates, Inc. · 1996
- Descendant · cites it directly · 7 of its ownK972278 Cytoplast Regentex Titanium 250Osteogenics Co. · 1997 · Recalled
- Descendant · cites it directly · 2 of its ownK143327 Neoss Ti Reinforced MembraneNeoss, Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK201187 Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK091120 Medpor Contain ImplantPorex Surgical, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK221851 Lumina-PTFE TitaniumCriteria Industria E Comercio DE Produtos Medicinais · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K972278Cytoplast Regentex Titanium 250Osteogenics Co. · 1997 · cites it directly7descendants
- K143327Neoss Ti Reinforced MembraneNeoss, Ltd. · 2015 · cites it directly2descendants
- K201187Cytoplast Titanium-Reinforced PTFE MembranesOsteogenics Biomedical, Inc. · 2021 · 2 generations on1descendant
- K091120Medpor Contain ImplantPorex Surgical, Inc. · 2010 · 2 generations on1descendant
- K221851Lumina-PTFE TitaniumCriteria Industria E Comercio DE Produtos Medicinais · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960292 | Gore-Tex Regenerative Material Titanium Reinforced Configurations | W. L. Gore & Associates, Inc. | 1996 | — |
| +1 | K972278 | Cytoplast Regentex Titanium 250 | Osteogenics Co. | 1997 | 1 |
| +1 | K143327 | Neoss Ti Reinforced Membrane | Neoss, Ltd. | 2015 | — |
| +2 | K201187 | Cytoplast Titanium-Reinforced PTFE Membranes | Osteogenics Biomedical, Inc. | 2021 | — |
| +2 | K091120 | Medpor Contain Implant | Porex Surgical, Inc. | 2010 | — |
| +3 | K221851 | Lumina-PTFE Titanium | Criteria Industria E Comercio DE Produtos Medicinais | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NPK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NPK device
- #1 K221851 Lumina-PTFE Titaniumscore 7.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | GORE-TEX Periodontal Material -- Titanium Reinforced Configurations Named without a submission number |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K972278 (Osteogenics Co., 1997) has gone furthest, with 7 descendants of its own.
How does its category compare?
All NPK devicesNPK Barrier, Synthetic, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NPK
3in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NPK
529in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPK
No recall names NPK since 2007.
Adverse event reports per year · NPK
3in 2022
MAUDE reports naming product code NPK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 2 | — | 0 | 13 |
| 2011 | 1 | — | 0 | 35 |
| 2012 | 0 | — | 0 | 17 |
| 2013 | 1 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 3 | 529 | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K960292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960292: Gore-Tex Regenerative Material Titanium Reinforced Configurations.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960292
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026