510(k) · Cleared
ClearedMucograft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ed. Geistlich Soehne AG Fur Chemische Industrie · NPL Barrier, Animal Source, Intraoral
Cleared on Nov 17, 2010 as substantially equivalent to K012423 (Ed. Geistlich Soehne AG Fuer Chemische Industrie, 2003) and 4 other predicates after a 75-day review. Its family tree reaches back 6 generations to 1995. 13 later devices descend from it.
- Decided
- Nov 17, 2010
- Review
- 75 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K924408 (1995). 10 ancestors in all. 13 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK924408 Colla-Tec Absorbable Collagen MembraneColla-Tec, Inc. · 1995 · Recalled
- 5 generations backK992216 Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable…Integra Lifesciences Corp. · 1999 · Recalled
- 4 generations backK042197 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone…Ed. Geistlich Soehne AG Fuer Chemische Industrie · 2004
- 3 generations backK050446 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneEd. Geistlich Soehne AG Fuer Chemische Industrie · 2005
- 2 generations backK061244 MucograftEd. Geistlich Soehne AG Fuer Chemische Industrie · 2006
- 1 generation backK073711 Mucograft Collagen MatrixEd. Geistlich Soehne AG Fuer Chemische Industrie · 2008
- This deviceK102531 MucograftEd. Geistlich Soehne AG Fur Chemische Industrie · 2010
- Descendant · cites it directly · 10 of its ownK140518 Geistlich Mucograft: 15 X 20 MM, 20 X 30 MM, 8 MM DiameterGeistlich Pharma AG · 2014
- Descendant · cites it directly · 9 of its ownK192042 Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide…Geistlich Pharma AG · 2019
- Descendant · 2 generations on · 3 of its ownK212463 Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide…Geistlich Pharma AG · 2022
- Descendant · cites it directly · 3 of its ownK210280 Geistlich Mucograft®, Geistlich Mucograft® SealGeistlich Pharma AG · 2021
- Descendant · cites it directly · 1 of its ownK171050 Geistlich Fibro-GideGeistlich Pharma AG · 2017
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K140518Geistlich Mucograft: 15 X 20 MM, 20 X 30 MM, 8 MM DiameterGeistlich Pharma AG · 2014 · cites it directly10descendants
- K192042Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich…Geistlich Pharma AG · 2019 · cites it directly9descendants
- K212463Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich…Geistlich Pharma AG · 2022 · 2 generations on3descendants
- K210280Geistlich Mucograft®, Geistlich Mucograft® SealGeistlich Pharma AG · 2021 · cites it directly3descendants
- K171050Geistlich Fibro-GideGeistlich Pharma AG · 2017 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924408 | Colla-Tec Absorbable Collagen Membrane | Colla-Tec, Inc. | 1995 | 2 |
| −5 | K992216 | Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen… | Integra Lifesciences Corp. | 1999 | 1 |
| −4 | K042197 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2004 | — |
| −3 | K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2005 | — |
| −2 | K061244 | Mucograft | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2006 | — |
| −1 | K073711 | Mucograft Collagen Matrix | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2008 | — |
| 0 (this device) | K102531 | Mucograft | Ed. Geistlich Soehne AG Fur Chemische Industrie | 2010 | — |
| +1 | K140518 | Geistlich Mucograft: 15 X 20 MM, 20 X 30 MM, 8 MM Diameter | Geistlich Pharma AG | 2014 | — |
| +1 | K192042 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed… | Geistlich Pharma AG | 2019 | — |
| +2 | K212463 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed… | Geistlich Pharma AG | 2022 | — |
| +1 | K210280 | Geistlich Mucograft®, Geistlich Mucograft® Seal | Geistlich Pharma AG | 2021 | — |
| +1 | K171050 | Geistlich Fibro-Gide | Geistlich Pharma AG | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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 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? (5)
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 |
|---|---|---|---|
| * | K012423 | MucograftSummary page 1…DEVICE NAME Proprietary Namé ~~ MUCOGRAFT® Common/Usual Name: . Collagen Matrix Classification Name: Barrier, Animal Source, Dental 3. PREDICATE DEVICES MUCOGRAFT® (K012423, K061244 and K073711) DYNAMATRIX K010952 . _ INTENDED USE MUCOGRAFT® Collagen Matrix currently is indicated for: - Simultaneous… | 2003 |
| * | K061244 | MucograftSummary page 1…AME Proprietary Namé ~~ MUCOGRAFT® Common/Usual Name: . Collagen Matrix Classification Name: Barrier, Animal Source, Dental 3. PREDICATE DEVICES MUCOGRAFT® (K012423, K061244 and K073711) DYNAMATRIX K010952 . _ INTENDED USE MUCOGRAFT® Collagen Matrix currently is indicated for: - Simultaneous use of G… | 2006 |
| * | K073711 | Mucograft Collagen MatrixSummary page 1…tary Namé ~~ MUCOGRAFT® Common/Usual Name: . Collagen Matrix Classification Name: Barrier, Animal Source, Dental 3. PREDICATE DEVICES MUCOGRAFT® (K012423, K061244 and K073711) DYNAMATRIX K010952 . _ INTENDED USE MUCOGRAFT® Collagen Matrix currently is indicated for: - Simultaneous use of GBR-membrane… | 2008 |
| * | K010952 | Surgisis Guided Tissue Regeneration MatrixSummary page 1…FT® Common/Usual Name: . Collagen Matrix Classification Name: Barrier, Animal Source, Dental 3. PREDICATE DEVICES MUCOGRAFT® (K012423, K061244 and K073711) DYNAMATRIX K010952 . _ INTENDED USE MUCOGRAFT® Collagen Matrix currently is indicated for: - Simultaneous use of GBR-membrane (MUCOGRAFT) and impl… | 2002 |
| * | K082058 | DynamatrixSummary page 2…BSTANTIAL EQUIVALENCE MUCOGRAFT@ collagen matrix is substantially equivalent to Geistlich's existing products MUCOGRAFT® (K012423, K061244 and K073711) and DYNAMATRIX® (K082058 and K010952). The current 510(k) requests clearance of MUCOGRAFT® for a- revised set of indications regarding guided tissue regen… | 2008 |
What descends from it? (13)
See all 135 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140518 | Geistlich Mucograft: 15 X 20 MM, 20 X 30 MM, 8 MM Diameter | 2014 | 10 |
| K192042 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich… | 2019 | 9 |
| K210280 | Geistlich Mucograft®, Geistlich Mucograft® Seal | 2021 | 3 |
| K171050 | Geistlich Fibro-Gide | 2017 | 1 |
| K192612 | Kerecis Gingiva Graft | 2020 | 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 15 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K140518 (Geistlich Pharma AG, 2014) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K012423.
How does its category compare?
All NPL devicesNPL Barrier, Animal Source, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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?
covering of implants placed in immediate or delayed extraction sockets;
localized gingival augmentation to increase keratinized tissue (KT) around teeth and implants;
alveolar ridge reconstruction for prosthetic treatment;
guided tissue regeneration procedures in recession defects for root coverage
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/K102531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102531: Mucograft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102531
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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