510(k) · Cleared
ClearedImtec/Biobarrier Membrane
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imtec Corp. · NPK Barrier, Synthetic, Intraoral
Cleared on Mar 3, 1998 as substantially equivalent to K960724 (Geistlich-Pharma, 1997) after a 74-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.
- Decided
- Mar 3, 1998
- Review
- 74 days
- Class
- Class II
- Product code
- NPK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K960724 (1997). 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK960724 Bio-Gide Resorbable Bilayer MembraneGeistlich-Pharma · 1997
- This deviceK974752 Imtec/Biobarrier MembraneImtec Corp. · 1998
- Descendant · cites it directly · 2 of its ownK012144 CytoflexUnicare Biomedical, Inc. · 2001
- Descendant · 2 generations on · 1 of its ownK160493 Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg…Salvin Dental Specialties · 2016
- Descendant · 3 generations on · 0 of its ownK222549 OpenTexPurgo Biologics, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK113049 Socket GraftSteiner Laboratories · 2012
Most influential descendants
Showing 4 of 4 · See all- K012144CytoflexUnicare Biomedical, Inc. · 2001 · cites it directly2descendants
- K160493Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE…Salvin Dental Specialties · 2016 · 2 generations on1descendant
- K222549OpenTexPurgo Biologics, Inc. · 2023 · 3 generations on0descendants
- K113049Socket GraftSteiner Laboratories · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960724 | Bio-Gide Resorbable Bilayer Membrane | Geistlich-Pharma | 1997 | — |
| 0 (this device) | K974752 | Imtec/Biobarrier Membrane | Imtec Corp. | 1998 | — |
| +1 | K012144 | Cytoflex | Unicare Biomedical, Inc. | 2001 | — |
| +2 | K160493 | Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable… | Salvin Dental Specialties | 2016 | — |
| +3 | K222549 | OpenTex | Purgo Biologics, Inc. | 2023 | — |
| +1 | K113049 | Socket Graft | Steiner Laboratories | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K960724 | Bio-Gide Resorbable Bilayer MembraneSummary page 1…RANE, 76LYC. Common/ Usual Name: GUIDED TISSUE MEMBRANE, PTFE. Proprietary Name: IMTEC/ BIOBARRIER MEMBRANE (K950306 / K972240) PREDICATE DEVICE: Osteohealth, Bio-gide, K960724 DEVICE DESCRIPTION: IMTEC/BIOBARRIER is a non-absorbable guided tissue membrane composed of 100% Polytetrafluoroethylene. It is… | 1997 |
What descends from it? (4)
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?
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?
IMTEC BioBarrier is a temporarily implantable material intended to be used as a space maintaining barrier over bone. It is intended for use in the oral cavity. The material is conformable to a variety of shapes as required for specific anatomical limitations. The IMTEC BioBarrier is additionally indicated for: - simultaneous use of GBR-membrane (BioBarrier) and implants: - augmentation around implants placed in immediate extraction sockets; -…
Read the full statement (105 words)
IMTEC BioBarrier is a temporarily implantable material intended to be used as a space maintaining barrier over bone. It is intended for use in the oral cavity. The material is conformable to a variety of shapes as required for specific anatomical limitations.
The IMTEC BioBarrier is additionally indicated for:
- simultaneous use of GBR-membrane (BioBarrier) and implants:
- augmentation around implants placed in immediate extraction sockets;
- augmentation around implants placed in delayed extraction sockets;
- localized ridge augmentation for later implantation.
Because of its elasticity, the IMTEC BioBarrier should be used in combination with space-making bone graft materials, e.g., autogenous bone or bone substitutes.
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/K974752 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974752: Imtec/Biobarrier Membrane.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974752
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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