510(k) · Cleared
ClearedGeistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack
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 Apr 5, 2022 as substantially equivalent to K192042 (Geistlich Pharma AG, 2019) after a 242-day review. Its family tree reaches back 9 generations to 1995. 3 later devices descend from it.
- Decided
- Apr 5, 2022
- Review
- 242 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 1
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 deviceK212463 Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide…Geistlich Pharma AG · 2022
- Descendant · cites it directly · 0 of its ownK253317 Cytrans™ ElashieldGC America, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK251062 Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide®…Geistlich Pharma AG · 2025
- Descendant · cites it directly · 0 of its ownK250833 SwissMembrane X; SwissMembrane X SocketGeistlich Pharma AG · 2025
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 deviceK212463 Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide…Geistlich Pharma AG · 2022
Most influential descendants
Showing 3 of 3 · See all- K253317Cytrans™ ElashieldGC America, Inc. · 2026 · cites it directly0descendants
- K251062Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich…Geistlich Pharma AG · 2025 · cites it directly0descendants
- K250833SwissMembrane X; SwissMembrane X SocketGeistlich Pharma AG · 2025 · 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) | K212463 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed… | Geistlich Pharma AG | 2022 | — |
| +1 | K253317 | Cytrans™ Elashield | GC America, Inc. | 2026 | — |
| +1 | K251062 | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed… | Geistlich Pharma AG | 2025 | — |
| +1 | K250833 | SwissMembrane X; SwissMembrane X Socket | 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 |
|---|---|---|
| 2025 | 2 | 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 K250512 Augmented Gingival Matrixscore 13.2 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 9…NPL Device Classification II III. Predicate Device Substantial equivalence is claimed to the following device: • Geistlich Bio-Gide®, K192042, Geistlich Pharma AG IV. Device Description Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. Th… | 2019 |
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 27 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 26 ancestors have a recall of any class.
- Of its descendants, K253317 (GC America, Inc., 2026) 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. 2022, 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 (578 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@ 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@ 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@ 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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212463 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212463: Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212463
Report an extraction error
Are you the manufacturer?
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