510(k) · Cleared
ClearedOpenTex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Purgo Biologics, Inc. · NPK Barrier, Synthetic, Intraoral
Cleared on May 11, 2023 as substantially equivalent to K160493 (Salvin Dental Specialties, 2016) after a 261-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- May 11, 2023
- Review
- 261 days
- Class
- Class II
- Product code
- NPK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K922627 (1994). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK922627 Gore-Tex Regenerative MaterialW. L. Gore & Associates, Inc. · 1994
- 3 generations backK964342 Cytoplast GBROsteogenics Co. · 1997
- 2 generations backK012144 CytoflexUnicare Biomedical, Inc. · 2001
- 1 generation backK160493 Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg…Salvin Dental Specialties · 2016
- This deviceK222549 OpenTexPurgo Biologics, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922627 | Gore-Tex Regenerative Material | W. L. Gore & Associates, Inc. | 1994 | — |
| −3 | K964342 | Cytoplast GBR | Osteogenics Co. | 1997 | — |
| −2 | K012144 | Cytoflex | Unicare Biomedical, Inc. | 2001 | — |
| −1 | K160493 | Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable… | Salvin Dental Specialties | 2016 | — |
| 0 (this device) | K222549 | OpenTex | Purgo Biologics, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K160493 | Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE…Summary page 4…rrier, Synthetic, Intraoral Device class : Class II Classification Panel : Dental 3. Predicate Device Primary predicate device K160493 Salvin CytoSurgTM Non-Resorbable PTFE Membrane Reference device K964342 Cytoplast GBR 510(k) Summary… | 2016 |
| † | K964342 | Cytoplast GBR | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 5 companies; a new generation was cleared every 6.7 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All NPK devicesNPK Barrier, Synthetic, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
OpenTex is a temporarily implantable material (non-resorbable) for as a space-making barrier in the treatment of periodontal defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222549 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222549: OpenTex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222549
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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