510(k) · Cleared
ClearedStraumann Membragel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Straumann AG · NPK Barrier, Synthetic, Intraoral
Cleared on May 22, 2009 as substantially equivalent to K050446 (Ed. Geistlich Soehne AG Fuer Chemische Industrie, 2005) and 1 other predicate after a 298-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- May 22, 2009
- Review
- 298 days
- Class
- Class II
- Product code
- NPK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K924408 (1995). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK924408 Colla-Tec Absorbable Collagen MembraneColla-Tec, Inc. · 1995 · Recalled
- 3 generations backK992216 Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable…Integra Lifesciences Corp. · 1999 · Recalled
- 2 generations backK042197 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone…Ed. Geistlich Soehne AG Fuer Chemische Industrie · 2004
- 1 generation backK050446 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneEd. Geistlich Soehne AG Fuer Chemische Industrie · 2005
- This deviceK082111 Straumann MembragelInstitut Straumann AG · 2009
- Descendant · cites it directly · 0 of its ownK101956 Straumann MembragelStraumann USA (On Behalf of Institut Straumann Ag) · 2010
Most influential descendants
Showing 1 of 1 · See all- K101956Straumann MembragelStraumann USA (On Behalf of Institut Straumann Ag) · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924408 | Colla-Tec Absorbable Collagen Membrane | Colla-Tec, Inc. | 1995 | 2 |
| −3 | K992216 | Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen… | Integra Lifesciences Corp. | 1999 | 1 |
| −2 | K042197 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2004 | — |
| −1 | K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2005 | — |
| 0 (this device) | K082111 | Straumann Membragel | Institut Straumann AG | 2009 | — |
| +1 | K101956 | Straumann Membragel | Straumann USA (On Behalf of Institut Straumann Ag) | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 |
|---|---|---|---|
| * | K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneSummary page 1…egally Marketed Device to which Equivalence is Claimed (Predicate Device) BIO-GIDE® Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration (K050446) ATRISORB® FreeFlowTm GTR Barrier (K982865) 4. Description of the Device Straumann® MembraGel is a steril… | 2005 |
| * | K982865 | Atrisorb Bioabsorbable Guided Tissue Regeneration (GTR) Barrier KitSummary page 1…ed (Predicate Device) BIO-GIDE® Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration (K050446) ATRISORB® FreeFlowTm GTR Barrier (K982865) 4. Description of the Device Straumann® MembraGel is a sterile, synthetic, biodegradable barrier membrane for… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101956 | Straumann Membragel | 2010 | 0 |
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 14 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K101956 (Straumann USA (On Behalf of Institut Straumann Ag), 2010) has gone furthest, with 0 descendants of its own.
- 16 other devices also cite its predicate K050446.
How does its category compare?
All NPK devicesNPK Barrier, Synthetic, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Straumann MembraGel is a biodegradable, synthetic, in situ forming hydrogel material. It is infended to aid in the regeneration and integration of oral tissue components in guided bone regeneration procedures. This includes the surgical treatment of peri-implant defects, bone defects, deficient alveolar ridges, and extraction sockets.
Because Straumann MembraGel is not self supporting it must be used in combination with a bone graft material in order to maintain space under the membrane.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082111 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082111: Straumann Membragel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082111
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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