510(k) · Cleared
ClearedNeoss Ti Reinforced Membrane
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neoss, Ltd. · NPK Barrier, Synthetic, Intraoral
Cleared on Apr 13, 2015 as substantially equivalent to K960292 (W. L. Gore & Associates, Inc., 1996) and 1 other predicate after a 144-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Apr 13, 2015
- Review
- 144 days
- Class
- Class II
- Product code
- NPK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K922627 (1994). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK922627 Gore-Tex Regenerative MaterialW. L. Gore & Associates, Inc. · 1994
- 2 generations backK964342 Cytoplast GBROsteogenics Co. · 1997
- 1 generation backK972278 Cytoplast Regentex Titanium 250Osteogenics Co. · 1997 · Recalled
- This deviceK143327 Neoss Ti Reinforced MembraneNeoss, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK210797 Bio-MEM Ti Reinforced MembraneB&Medi Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK151344 Cytoflex Tefguard Ti-Enforced MembraneUnicare Biomedical, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K922627 | Gore-Tex Regenerative Material | W. L. Gore & Associates, Inc. | 1994 | — |
| −2 | K964342 | Cytoplast GBR | Osteogenics Co. | 1997 | — |
| −1 | K972278 | Cytoplast Regentex Titanium 250 | Osteogenics Co. | 1997 | 1 |
| 0 (this device) | K143327 | Neoss Ti Reinforced Membrane | Neoss, Ltd. | 2015 | — |
| +1 | K210797 | Bio-MEM Ti Reinforced Membrane | B&Medi Co., Ltd. | 2022 | — |
| +1 | K151344 | Cytoflex Tefguard Ti-Enforced Membrane | Unicare Biomedical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2022 | 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? (2)
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 |
|---|---|---|---|
| * | K960292 | Gore-Tex Regenerative Material Titanium Reinforced ConfigurationsSummary page 4…Reinforced Membrane Common Name: Nonresorbable Barrier membrane Regulatory Class: II Regulation: 872.3930 Bone grafting material. Product Code: NPK Predicate Device(s): K960292 Gore-Tex Regenerative Material Ti Reinforced Configurations, K972278 Osteogenics Cytoplast Regentex Ti 250 Device Description:… | 1996 |
| * | K972278 | Cytoplast Regentex Titanium 250Summary page 4…latory Class: II Regulation: 872.3930 Bone grafting material. Product Code: NPK Predicate Device(s): K960292 Gore-Tex Regenerative Material Ti Reinforced Configurations, K972278 Osteogenics Cytoplast Regentex Ti 250 Device Description: The Neoss Ti Reinforced Membrane a multi-layer non-resorbable dental… | 1997 |
What descends from it? (2)
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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K210797 (B&Medi Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K960292.
How does its category compare?
All NPK devicesNPK Barrier, Synthetic, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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?
An implantable temporary non-resorbable device (membrane) for use as a spacer creation barrier in the treatment of local defects in the oral cavity in conjunction with tissue regeneration or augmentation. Neoss Ti Reinforced Membranes are intended to be submerged and clinically implanted more than 30 days with an expected duration of implantation up of 6 months.
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/K143327 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143327: Neoss Ti Reinforced Membrane.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143327
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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