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 Fuer Chemische Industrie · NPL Barrier, Animal Source, Intraoral
Cleared on Jan 24, 2003 after a 543-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 17 later devices descend from it.
- Decided
- Jan 24, 2003
- Review
- 543 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 4 citing it directly.
- This deviceK012423 MucograftEd. Geistlich Soehne AG Fuer Chemische Industrie · 2003
- 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
- Descendant · cites it directly · 13 of its ownK102531 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 · 2 generations on · 9 of its ownK192042 Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide…Geistlich Pharma AG · 2019
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K061244MucograftEd. Geistlich Soehne AG Fuer Chemische Industrie · 2006 · cites it directly16descendants
- K073711Mucograft Collagen MatrixEd. Geistlich Soehne AG Fuer Chemische Industrie · 2008 · cites it directly15descendants
- K102531MucograftEd. Geistlich Soehne AG Fur Chemische Industrie · 2010 · cites it directly13descendants
- 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 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012423 | Mucograft | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2003 | — |
| +1 | K061244 | Mucograft | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2006 | — |
| +1 | K073711 | Mucograft Collagen Matrix | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2008 | — |
| +1 | 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 | — |
| +2 | K192042 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed… | Geistlich Pharma AG | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (17)
See all 174 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?
- Of its descendants, K061244 (Ed. Geistlich Soehne AG Fuer Chemische Industrie, 2006) has gone furthest, with 16 descendants of its own.
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?
INDICATIONS:
MUCOGRAFT® is indicated for:
- simultaneous use of GBR-membrane (MUCOGRAFTB) 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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012423 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012423: Mucograft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012423
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026