510(k) · Cleared
ClearedInterCollagen® Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigmagraft, Inc. · NPL Barrier, Animal Source, Intraoral
Cleared on Aug 17, 2023 as substantially equivalent to K173562 (Institut Straumann AG, 2018) after a 231-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Aug 17, 2023
- Review
- 231 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K924408 (1995). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK924408 Colla-Tec Absorbable Collagen MembraneColla-Tec, Inc. · 1995 · Recalled
- 6 generations backK992216 Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable…Integra Lifesciences Corp. · 1999 · Recalled
- 5 generations backK042197 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone…Ed. Geistlich Soehne AG Fuer Chemische Industrie · 2004
- 4 generations backK050446 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneEd. Geistlich Soehne AG Fuer Chemische Industrie · 2005
- 3 generations backK101453 Vitala Natural Resorbable Collagen MembraneObi Biologics, Inc. · 2011
- 2 generations backK141177 Vitala Porcine Derived Collagen MembraneOsteogenics Biomedical, Inc. (Formerly Obi Biologi · 2015
- 1 generation backK173562 Straumann Jason MembraneInstitut Straumann AG · 2018
- This deviceK223912 InterCollagen® GuideSigmagraft, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K924408 | Colla-Tec Absorbable Collagen Membrane | Colla-Tec, Inc. | 1995 | 2 |
| −6 | K992216 | Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen… | Integra Lifesciences Corp. | 1999 | 1 |
| −5 | K042197 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2004 | — |
| −4 | K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2005 | — |
| −3 | K101453 | Vitala Natural Resorbable Collagen Membrane | Obi Biologics, Inc. | 2011 | — |
| −2 | K141177 | Vitala Porcine Derived Collagen Membrane | Osteogenics Biomedical, Inc. (Formerly Obi Biologi | 2015 | — |
| −1 | K173562 | Straumann Jason Membrane | Institut Straumann AG | 2018 | — |
| 0 (this device) | K223912 | InterCollagen® Guide | Sigmagraft, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K173562 | Straumann Jason MembraneSummary page 4…L Classification Panel: Dental Predicate Device Primary Predicate: Straumann Jason Membrane (K173562) Common Name: Bone Grafting Material Classification Name:… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 7 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K173562.
How does its category compare?
All NPL devicesNPL Barrier, Animal Source, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
InterCollagen® Guide alone or in combination with suitable augmentation materials (like autogenous bone, allogeneic, xenogeneic or alloplastic bone replacement materials) is indicated for immediate or delayed guided tissue and bone regeneration.
• in the context of a treatment of fenestration defects
• in case of dehiscence defects
• after apicoectomy and resection of retained teeth
• in extraction sockets after tooth extractions
• in case of immediate or delayed augmentation around implants in extraction sockets
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223912 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223912: InterCollagen® Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223912
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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