510(k) · Cleared
ClearedGeistlich Mucograft®, Geistlich Mucograft® Seal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geistlich Pharma AG · NPL Barrier, Animal Source, Intraoral
Cleared on Mar 3, 2021 as substantially equivalent to K192042 (Geistlich Pharma AG, 2019) and 3 other predicates after a 30-day review. Its family tree reaches back 9 generations to 1995. 3 later devices descend from it.
- Decided
- Mar 3, 2021
- Review
- 30 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K924408 (1995). 26 ancestors in all, the oldest K871773 (1987). 3 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK924408 Colla-Tec Absorbable Collagen MembraneColla-Tec, Inc. · 1995 · Recalled
- 5 generations between
- 3 generations backK102531 MucograftEd. Geistlich Soehne AG Fur Chemische Industrie · 2010
- 2 generations backK140518 Geistlich Mucograft: 15 X 20 MM, 20 X 30 MM, 8 MM DiameterGeistlich Pharma AG · 2014
- 1 generation backK192042 Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide…Geistlich Pharma AG · 2019
- This deviceK210280 Geistlich Mucograft®, Geistlich Mucograft® SealGeistlich Pharma AG · 2021
- Descendant · cites it directly · 0 of its ownK250512 Augmented Gingival MatrixNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK252253 Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®Geistlich Pharma AG · 2025
- Descendant · cites it directly · 0 of its ownK233203 Soft Tissue Augmentation Resorbable MatrixCollagen Matrix, Inc. · 2024
Show all 9 generations
- Root · 9 generations backK924408 Colla-Tec Absorbable Collagen MembraneColla-Tec, Inc. · 1995 · Recalled
- 8 generations backK992216 Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable…Integra Lifesciences Corp. · 1999 · Recalled
- 7 generations backK042197 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone…Ed. Geistlich Soehne AG Fuer Chemische Industrie · 2004
- 6 generations backK050446 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneEd. Geistlich Soehne AG Fuer Chemische Industrie · 2005
- 5 generations backK061244 MucograftEd. Geistlich Soehne AG Fuer Chemische Industrie · 2006
- 4 generations backK073711 Mucograft Collagen MatrixEd. Geistlich Soehne AG Fuer Chemische Industrie · 2008
- 3 generations backK102531 MucograftEd. Geistlich Soehne AG Fur Chemische Industrie · 2010
- 2 generations backK140518 Geistlich Mucograft: 15 X 20 MM, 20 X 30 MM, 8 MM DiameterGeistlich Pharma AG · 2014
- 1 generation backK192042 Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide…Geistlich Pharma AG · 2019
- This deviceK210280 Geistlich Mucograft®, Geistlich Mucograft® SealGeistlich Pharma AG · 2021
Most influential descendants
Showing 3 of 3 · See all- K250512Augmented Gingival MatrixNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. · 2025 · cites it directly0descendants
- K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®Geistlich Pharma AG · 2025 · cites it directly0descendants
- K233203Soft Tissue Augmentation Resorbable MatrixCollagen Matrix, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K924408 | Colla-Tec Absorbable Collagen Membrane | Colla-Tec, Inc. | 1995 | 2 |
| −8 | K992216 | Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen… | Integra Lifesciences Corp. | 1999 | 1 |
| −7 | K042197 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2004 | — |
| −6 | K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2005 | — |
| −5 | K061244 | Mucograft | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2006 | — |
| −4 | K073711 | Mucograft Collagen Matrix | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2008 | — |
| −3 | K102531 | Mucograft | Ed. Geistlich Soehne AG Fur Chemische Industrie | 2010 | — |
| −2 | 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 | — |
| 0 (this device) | K210280 | Geistlich Mucograft®, Geistlich Mucograft® Seal | Geistlich Pharma AG | 2021 | — |
| +1 | K250512 | Augmented Gingival Matrix | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. | 2025 | — |
| +1 | K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® | Geistlich Pharma AG | 2025 | — |
| +1 | K233203 | Soft Tissue Augmentation Resorbable Matrix | Collagen Matrix, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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? (4)
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 |
|---|---|---|---|
| * | K192042 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich…Summary page 4…ubstantial equivalence is claimed to the following devices: Product Name 510(k) Applicant Geistlich Mucograft® and Mucograft® Seal K192042 Geistlich Pharma AG K140518 Geistlich Pharma AG… | 2019 |
| * | K140518 | Geistlich Mucograft: 15 X 20 MM, 20 X 30 MM, 8 MM DiameterSummary page 4…510(k) Applicant Geistlich Mucograft® and Mucograft® Seal K192042 Geistlich Pharma AG K140518 Geistlich Pharma AG K102531 Geistlich Pharma AG… | 2014 |
| * | K102531 | MucograftSummary page 4…d Mucograft® Seal K192042 Geistlich Pharma AG K140518 Geistlich Pharma AG K102531 Geistlich Pharma AG K073711 Geistlich Pharma AG IV. Device Description Gei… | 2010 |
| * | K073711 | Mucograft Collagen MatrixSummary page 4…K140518 Geistlich Pharma AG K102531 Geistlich Pharma AG K073711 Geistlich Pharma AG IV. Device Description Geistlich Mucograft® and Geistlich Mucograft® Seal are surgically implanted, f… | 2008 |
What descends from it? (3)
3 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?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K250512 (Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K192042.
How does its category compare?
All NPL devicesNPL Barrier, Animal Source, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Geistlich Mucograft® and Geistlich Mucograft® Seal are 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; and
• recession defects for root coverage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210280: Geistlich Mucograft®, Geistlich Mucograft® Seal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210280
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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