510(k) · Cleared
ClearedBio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ed. Geistlich Soehne AG Fuer Chemische Industrie · NPL Barrier, Animal Source, Intraoral
Cleared on Nov 15, 2004 as substantially equivalent to K960724 (Geistlich-Pharma, 1997) and 1 other predicate after a 94-day review. Its family tree reaches back 2 generations to 1995. 58 later devices descend from it.
- Decided
- Nov 15, 2004
- Review
- 94 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K924408 (1995). 3 ancestors in all. 58 later devices descend from it, 12 citing it directly.
- Root · 2 generations backK924408 Colla-Tec Absorbable Collagen MembraneColla-Tec, Inc. · 1995 · Recalled
- 1 generation backK992216 Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable…Integra Lifesciences Corp. · 1999 · Recalled
- This deviceK042197 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone…Ed. Geistlich Soehne AG Fuer Chemische Industrie · 2004
- Descendant · cites it directly · 53 of its ownK050446 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneEd. Geistlich Soehne AG Fuer Chemische Industrie · 2005
- Descendant · cites it directly · 23 of its ownK112572 Geistlich Combi-Kit CollegenGeistlich Pharma AG · 2011
- Descendant · 2 generations on · 21 of its ownK122894 Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit…Geistlich Pharma AG · 2013
- Descendant · cites it directly · 16 of its ownK061244 MucograftEd. Geistlich Soehne AG Fuer Chemische Industrie · 2006
- Descendant · cites it directly · 15 of its ownK073711 Mucograft Collagen MatrixEd. Geistlich Soehne AG Fuer Chemische Industrie · 2008
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K050446Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneEd. Geistlich Soehne AG Fuer Chemische Industrie · 2005 · cites it directly53descendants
- K112572Geistlich Combi-Kit CollegenGeistlich Pharma AG · 2011 · cites it directly23descendants
- K122894Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich…Geistlich Pharma AG · 2013 · 2 generations on21descendants
- K061244MucograftEd. Geistlich Soehne AG Fuer Chemische Industrie · 2006 · cites it directly16descendants
- K073711Mucograft Collagen MatrixEd. Geistlich Soehne AG Fuer Chemische Industrie · 2008 · cites it directly15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K924408 | Colla-Tec Absorbable Collagen Membrane | Colla-Tec, Inc. | 1995 | 2 |
| −1 | K992216 | Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen… | Integra Lifesciences Corp. | 1999 | 1 |
| 0 (this device) | 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 | — |
| +1 | K112572 | Geistlich Combi-Kit Collegen | Geistlich Pharma AG | 2011 | — |
| +2 | K122894 | Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen… | Geistlich Pharma AG | 2013 | — |
| +1 | K061244 | Mucograft | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2006 | — |
| +1 | K073711 | Mucograft Collagen Matrix | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 8 | 0 |
| 2026 | 2 | 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 NPL? 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 NPL device
- #1 K212463 Geistlich Bio-Gide, Geistlich Bio-Gide Shape…score 14.5 · 9 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 |
|---|---|---|---|
| * | K960724 | Bio-Gide Resorbable Bilayer MembraneSummary page 1…Regeneration Classification Name: Dental Bone Grafting Material 3. PREDICATE DEVICES BIO-GIDE®A (K960724) BioMend Extend® (K992 16) 4. INTENDED USE BLO-GIDE®k is recommended for:… | 1997 |
| * | K992216 | Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen MenbraneSummary page 2…guided tissue and bone regeneration is substantially equivalent to Geistlich's existing product, BIO-GIDE® (K960724), and BioMend ExtendTM (K992216). The only difference between the new product and the BIG-GIDE® product previously cleared is the additional indic… | 1999 |
What descends from it? (58)
See all 5812 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone | 2005 | 53 |
| K112572 | Geistlich Combi-Kit Collegen | 2011 | 23 |
| K061244 | Mucograft | 2006 | 16 |
| K073711 | Mucograft Collagen Matrix | 2008 | 15 |
| K112575 | Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide Perio | 2011 | 11 |
| K192042 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich… | 2019 | 9 |
| K100695 | Colladental Barrier | 2013 | 1 |
| K201241 | Striate+™ | 2021 | 0 |
| K160474 | DSM Biomedical Porcine Pericardium Dental Membrane | 2016 | 0 |
| K141909 | Collagen Dental Membrane - Conformable PP | 2014 | 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 9 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K050446 (Ed. Geistlich Soehne AG Fuer Chemische Industrie, 2005) has gone furthest, with 53 descendants of its own.
- 10 other devices also cite its predicate K960724.
How does its category compare?
All NPL devicesNPL Barrier, Animal Source, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NPL
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NPL
132in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NPL
6in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NPL
39in 2025
MAUDE reports naming product code NPL, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 172 | 0 | 0 |
| 2009 | 3 | 193 | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 4 | 286 | 0 | 0 |
| 2012 | 0 | — | 3 | 3 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 5 | 140 | 0 | 3 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 3 | 184 | 0 | 9 |
| 2017 | 3 | 200 | 0 | 18 |
| 2018 | 1 | — | 0 | 14 |
| 2019 | 1 | — | 6 | 22 |
| 2020 | 2 | — | 0 | 8 |
| 2021 | 2 | — | 0 | 11 |
| 2022 | 3 | 290 | 0 | 19 |
| 2023 | 2 | — | 0 | 5 |
| 2024 | 3 | 263 | 0 | 20 |
| 2025 | 5 | 132 | 0 | 39 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Simultaneous use of GBR-membrane and implants; augmentation around implants placed in immediate extraction sockets; augmentation around implants placed in delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects after root resection, cystectomy, removal of retained teeth; guided bone regeneration in dehiscence defects; guided tissue regeneration procedures in periodontal defects.
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/K042197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042197: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042197
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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