510(k) · Cleared
ClearedCollagen Dental Membrane IV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Collagen Matrix, Inc. · NPL Barrier, Animal Source, Intraoral
Cleared on Sep 18, 2009 as substantially equivalent to K062881 (Collagen Matrix, Inc., 2006) and 2 other predicates after a 232-day review. Its family tree reaches back 4 generations to 1995. 3 later devices descend from it.
- Decided
- Sep 18, 2009
- Review
- 232 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K924408 (1995). 8 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK924408 Colla-Tec Absorbable Collagen MembraneColla-Tec, Inc. · 1995 · Recalled
- 3 generations backK992216 Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable…Integra Lifesciences Corp. · 1999 · Recalled
- 2 generations backK042197 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone…Ed. Geistlich Soehne AG Fuer Chemische Industrie · 2004
- 1 generation backK050446 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneEd. Geistlich Soehne AG Fuer Chemische Industrie · 2005
- This deviceK090216 Collagen Dental Membrane IVCollagen Matrix, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK100156 Collagen Dental Membrane VCollagen Matrix, Inc. · 2010 · Recalled
- Descendant · cites it directly · 0 of its ownK142496 Collagen Dental Membrane - Conformable IIBPCollagen Matrix, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK141909 Collagen Dental Membrane - Conformable PPCollagen Matrix, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K100156Collagen Dental Membrane VCollagen Matrix, Inc. · 2010 · cites it directly1descendant
- K142496Collagen Dental Membrane - Conformable IIBPCollagen Matrix, Inc. · 2014 · cites it directly0descendants
- K141909Collagen Dental Membrane - Conformable PPCollagen Matrix, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924408 | Colla-Tec Absorbable Collagen Membrane | Colla-Tec, Inc. | 1995 | 2 |
| −3 | K992216 | Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen… | Integra Lifesciences Corp. | 1999 | 1 |
| −2 | K042197 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2004 | — |
| −1 | K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2005 | — |
| 0 (this device) | K090216 | Collagen Dental Membrane IV | Collagen Matrix, Inc. | 2009 | — |
| +1 | K100156 | Collagen Dental Membrane V | Collagen Matrix, Inc. | 2010 | 6 |
| +1 | K142496 | Collagen Dental Membrane - Conformable IIBP | Collagen Matrix, Inc. | 2014 | — |
| +2 | K141909 | Collagen Dental Membrane - Conformable PP | Collagen Matrix, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 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? (3)
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 |
|---|---|---|---|
| * | K062881 | Collagen Dental Menbrane - Conformable IISummary page 1…NPL Class II Predicate Device(s): Collagen Dental Membrane - Conformable II K062881 Bio-Gide TM Resorbable Bilayer Membrane for Guided Tissu… | 2006 |
| * | K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneSummary page 1…Bio-Gide TM Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration K050446 Tutodent® Dental Membrane CopiOsTM Pericardium Membrane… | 2005 |
| * | K073097 | Tutodent Dental MembraneSummary page 1…0446 Tutodent® Dental Membrane CopiOsTM Pericardium Membrane K073097 Description of the Device Collagen Dental Membrane IVis a white, nonfriable, conformable, resorbable, membrane matrix con… | 2008 |
What descends from it? (3)
2 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 14 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K100156 (Collagen Matrix, Inc., 2010) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K062881.
How does its category compare?
All NPL devicesNPL Barrier, Animal Source, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Collagen Dental Membrane IV is intended for use in oral surgical procedures as a resorbable membrane material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090216 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090216: Collagen Dental Membrane IV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090216
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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