510(k) · Cleared
ClearedGeistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and 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 Aug 29, 2019 as substantially equivalent to K960724 (Geistlich-Pharma, 1997) and 8 other predicates after a 29-day review. Its family tree reaches back 8 generations to 1995. 9 later devices descend from it.
- Decided
- Aug 29, 2019
- Review
- 29 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 8 generations to K924408 (1995). 25 ancestors in all, the oldest K871773 (1987). 9 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK924408 Colla-Tec Absorbable Collagen MembraneColla-Tec, Inc. · 1995 · Recalled
- 7 generations backK992216 Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable…Integra Lifesciences Corp. · 1999 · Recalled
- 6 generations backK042197 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone…Ed. Geistlich Soehne AG Fuer Chemische Industrie · 2004
- 5 generations backK050446 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneEd. Geistlich Soehne AG Fuer Chemische Industrie · 2005
- 4 generations backK061244 MucograftEd. Geistlich Soehne AG Fuer Chemische Industrie · 2006
- 3 generations backK073711 Mucograft Collagen MatrixEd. Geistlich Soehne AG Fuer Chemische Industrie · 2008
- 2 generations backK102531 MucograftEd. Geistlich Soehne AG Fur Chemische Industrie · 2010
- 1 generation backK140518 Geistlich Mucograft: 15 X 20 MM, 20 X 30 MM, 8 MM DiameterGeistlich Pharma AG · 2014
- This deviceK192042 Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide…Geistlich Pharma AG · 2019
- Descendant · cites it directly · 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 · 2 generations on · 0 of its ownK253317 Cytrans™ ElashieldGC America, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK250512 Augmented Gingival MatrixNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK252253 Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®Geistlich Pharma AG · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K212463Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich…Geistlich Pharma AG · 2022 · cites it directly3descendants
- K210280Geistlich Mucograft®, Geistlich Mucograft® SealGeistlich Pharma AG · 2021 · cites it directly3descendants
- K253317Cytrans™ ElashieldGC America, Inc. · 2026 · 2 generations on0descendants
- K250512Augmented Gingival MatrixNeo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. · 2025 · 2 generations on0descendants
- K252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®Geistlich Pharma AG · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K924408 | Colla-Tec Absorbable Collagen Membrane | Colla-Tec, Inc. | 1995 | 2 |
| −7 | K992216 | Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen… | Integra Lifesciences Corp. | 1999 | 1 |
| −6 | K042197 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2004 | — |
| −5 | K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2005 | — |
| −4 | K061244 | Mucograft | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2006 | — |
| −3 | K073711 | Mucograft Collagen Matrix | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2008 | — |
| −2 | 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 | — |
| 0 (this device) | K192042 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed… | Geistlich Pharma AG | 2019 | — |
| +1 | 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 | — |
| +2 | K253317 | Cytrans™ Elashield | GC America, Inc. | 2026 | — |
| +2 | K250512 | Augmented Gingival Matrix | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. | 2025 | — |
| +2 | K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® | Geistlich Pharma AG | 2025 | — |
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 |
|---|---|---|
| 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? (9)
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 10…II III. Predicate Device Substantial equivalence is claimed to the following devices: Product Name 510(k) Applicant Geistlich Bio-Gide® K960724 Geistlich Pharma AG K042197 Geistlich Pharma AG K050446 Geistlich Pharma… | 1997 |
| * | K042197 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone RegenerationSummary page 10…alence is claimed to the following devices: Product Name 510(k) Applicant Geistlich Bio-Gide® K960724 Geistlich Pharma AG K042197 Geistlich Pharma AG K050446 Geistlich Pharma AG K112572 Geistlich Pharma… | 2004 |
| * | K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneSummary page 10…ame 510(k) Applicant Geistlich Bio-Gide® K960724 Geistlich Pharma AG K042197 Geistlich Pharma AG K050446 Geistlich Pharma AG K112572 Geistlich Pharma AG The following device is referenced within the submi… | 2005 |
| * | K112572 | Geistlich Combi-Kit CollegenSummary page 10…K960724 Geistlich Pharma AG K042197 Geistlich Pharma AG K050446 Geistlich Pharma AG K112572 Geistlich Pharma AG The following device is referenced within the submission: • Geistlich Fibro-Gide, K171050, Geist… | 2011 |
| * | K171643 | Geistlich Bio-Gide Shape, Geistlich Bio-Gide CompressedSummary page 13…Predicate Device Substantial equivalence is claimed to the following devices: Product Name 510(k) Applicant Geistlich Bio-Gide® Shape K171643 Geistlich Pharma AG The following device is referenced within the submission: • Geistlich Fibro-Gide, K171050, Geist… | 2017 |
| * | K112575 | Geistlich Perio-System Combi-Pack , Geistlich Bio-Gide PerioSummary page 19…Predicate Device Substantial equivalence is claimed to the following devices: Product Name 510(k) Applicant Geistlich Bio-Gide® Perio K112575 Geistlich Pharma AG The following device is referenced within the submission: • Geistlich Fibro-Gide, K171050, Geist… | 2011 |
| * | K122894 | Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich…Summary page 22…ollowing devices: Product Name 510(k) Applicant Geistlich Combi-Kit Collagen K112572 Geistlich Pharma AG K122894 Geistlich Pharma AG The following device is referenced within the submission: • Geistlich Fibro-Gide, K171050, Geis… | 2013 |
| * | K140518 | Geistlich Mucograft: 15 X 20 MM, 20 X 30 MM, 8 MM DiameterSummary page 30…ubstantial equivalence is claimed to the following devices: Product Name 510(k) Applicant Geistlich Mucograft® and Mucograft® Seal K140518 Geistlich Pharma AG K102531 Geistlich Pharma AG The following device is refere… | 2014 |
| * | K102531 | MucograftSummary page 30…510(k) Applicant Geistlich Mucograft® and Mucograft® Seal K140518 Geistlich Pharma AG K102531 Geistlich Pharma AG The following device is referenced within the submission: • Geistlich Fibro-Gide, K171050, Geis… | 2010 |
| † | K171050 | Geistlich Fibro-Gide | 2017 |
What descends from it? (9)
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 24 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 25 ancestors have a recall of any class.
- Of its descendants, K212463 (Geistlich Pharma AG, 2022) has gone furthest, with 3 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. 2019, 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 Bio-Gide® is intended for the following uses: * 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; and * guided…
Read the full statement (625 words)
Geistlich Bio-Gide® is intended for the following uses:
* 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; and
* guided tissue regeneration procedures in periodontal defects.
Geistlich Bio-Gide® Shape is indicated for:
* 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.
Geistlich Bio-Gide® Compressed is indicated for:
* 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.
Geistlich Bio-Gide® Perio is intended for the following uses:
* 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; and
* guided tissue regeneration procedures in periodontal defects.
Geistlich Bio-Gide® is intended for the following uses:
* 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; and
* guided tissue regeneration procedures in periodontal defects.
Geistlich Bio-Oss Collagen® is intended for the following uses:
* augmentation or reconstructive treatment of the alveolar ridge;
* filling of periodontal defects;
* filling of defects after root resection, apicoectomy, and cystectomy;
* filling of extraction sockets to enhance preservation of the alveolar ridge;
* elevation of the maxillary sinus floor;
* filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
* filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Geistlich Bio-Gide® Perio is intended for the following uses:
* 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; and
* guided tissue regeneration procedures in periodontal defects.
Geistlich Bio-Oss Collagen® is intended for the following uses:
* augmentation or reconstructive treatment of the alveolar ridge;
* filling of periodontal defects;
* filling of defects after root resection, apicoectomy, and cystectomy;
* filling of extraction sockets to enhance preservation of the alveolar ridge;
* elevation of the maxillary sinus floor;
* filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
* filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192042: Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and 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/K192042
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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