510(k) · Cleared
Recalled · Class II · 2019Collagen Dental Membrane V
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 Aug 11, 2010 as substantially equivalent to K090216 (Collagen Matrix, Inc., 2009) and 1 other predicate after a 203-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it. It has been recalled 6 times.
- Decided
- Aug 11, 2010
- Review
- 203 days
- Class
- Class II
- Product code
- NPL
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 5 generations to K924408 (1995). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK924408 Colla-Tec Absorbable Collagen MembraneColla-Tec, Inc. · 1995 · Recalled
- 4 generations backK992216 Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable…Integra Lifesciences Corp. · 1999 · Recalled
- 3 generations backK042197 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone…Ed. Geistlich Soehne AG Fuer Chemische Industrie · 2004
- 2 generations backK050446 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneEd. Geistlich Soehne AG Fuer Chemische Industrie · 2005
- 1 generation backK090216 Collagen Dental Membrane IVCollagen Matrix, Inc. · 2009
- This deviceK100156 Collagen Dental Membrane VCollagen Matrix, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK141909 Collagen Dental Membrane - Conformable PPCollagen Matrix, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K141909Collagen Dental Membrane - Conformable PPCollagen Matrix, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924408 | Colla-Tec Absorbable Collagen Membrane | Colla-Tec, Inc. | 1995 | 2 |
| −4 | K992216 | Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen… | Integra Lifesciences Corp. | 1999 | 1 |
| −3 | K042197 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2004 | — |
| −2 | K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2005 | — |
| −1 | K090216 | Collagen Dental Membrane IV | Collagen Matrix, Inc. | 2009 | — |
| 0 (this device) | K100156 | Collagen Dental Membrane V | Collagen Matrix, Inc. | 2010 | — |
| +1 | 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 |
|---|---|---|
| 2014 | 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? (2)
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 |
|---|---|---|---|
| * | K090216 | Collagen Dental Membrane IVSummary page 1…NPL Class 11 Predicate Device(s): Collagen Dental Membrane IV K090216 Bio-GideTm Resorbable Bilayer Membrane for Guided Tissue and… | 2009 |
| * | K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneSummary page 1…Bio-GideTm Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration K050446 Description of the Device Collagen Dental Membrane V is a white, nonfriable, conformable, resorbable, membrane matrix consisting… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141909 | Collagen Dental Membrane - Conformable PP | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 5, 2019 | Class II | Z-0908-2020 | Labeling mix-ups | The products may have been packaged with an incorrect Instructions for Use. |
| Nov 5, 2019 | Class II | Z-0910-2020 | Labeling mix-ups | The products may have been packaged with an incorrect Instructions for Use. |
| Nov 5, 2019 | Class II | Z-0909-2020 | Labeling mix-ups | The products may have been packaged with an incorrect Instructions for Use. |
| Nov 5, 2019 | Class II | Z-0911-2020 | Labeling mix-ups | The products may have been packaged with an incorrect Instructions for Use. |
| Nov 5, 2019 | Class II | Z-0912-2020 | Labeling mix-ups | The products may have been packaged with an incorrect Instructions for Use. |
| Nov 5, 2019 | Class II | Z-0907-2020 | Labeling mix-ups | The products may have been packaged with an incorrect Instructions for Use. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K141909 (Collagen Matrix, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K090216.
How does its category compare?
All NPL devicesNPL Barrier, Animal Source, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 V 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/K100156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100156: Collagen Dental Membrane V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100156
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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