510(k) · Cleared
ClearedCollagen Dental Menbrane - Conformable II
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 Oct 11, 2006 as substantially equivalent to K011695 (Collagen Matrix, Inc., 2001) after a 15-day review. Its family tree reaches back 2 generations to 1997. 7 later devices descend from it.
- Decided
- Oct 11, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K960724 (1997). 7 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK960724 Bio-Gide Resorbable Bilayer MembraneGeistlich-Pharma · 1997
- 1 generation backK011695 Collagen Dental MembraneCollagen Matrix, Inc. · 2001 · Recalled
- This deviceK062881 Collagen Dental Menbrane - Conformable IICollagen Matrix, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK090216 Collagen Dental Membrane IVCollagen Matrix, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK100156 Collagen Dental Membrane VCollagen Matrix, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 0 of its ownK142496 Collagen Dental Membrane - Conformable IIBPCollagen Matrix, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK141909 Collagen Dental Membrane - Conformable PPCollagen Matrix, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK110600 Collagen Dental Mambrane - Porcine Type I CollagenCollagen Matrix, Inc. · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K090216Collagen Dental Membrane IVCollagen Matrix, Inc. · 2009 · cites it directly3descendants
- K100156Collagen Dental Membrane VCollagen Matrix, Inc. · 2010 · 2 generations on1descendant
- K142496Collagen Dental Membrane - Conformable IIBPCollagen Matrix, Inc. · 2014 · 2 generations on0descendants
- K141909Collagen Dental Membrane - Conformable PPCollagen Matrix, Inc. · 2014 · 3 generations on0descendants
- K110600Collagen Dental Mambrane - Porcine Type I CollagenCollagen Matrix, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960724 | Bio-Gide Resorbable Bilayer Membrane | Geistlich-Pharma | 1997 | — |
| −1 | K011695 | Collagen Dental Membrane | Collagen Matrix, Inc. | 2001 | 1 |
| 0 (this device) | K062881 | Collagen Dental Menbrane - Conformable II | Collagen Matrix, Inc. | 2006 | — |
| +1 | K090216 | Collagen Dental Membrane IV | Collagen Matrix, Inc. | 2009 | — |
| +2 | K100156 | Collagen Dental Membrane V | Collagen Matrix, Inc. | 2010 | 6 |
| +2 | K142496 | Collagen Dental Membrane - Conformable IIBP | Collagen Matrix, Inc. | 2014 | — |
| +3 | K141909 | Collagen Dental Membrane - Conformable PP | Collagen Matrix, Inc. | 2014 | — |
| +1 | K110600 | Collagen Dental Mambrane - Porcine Type I Collagen | Collagen Matrix, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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? (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 |
|---|---|---|---|
| * | K011695 | Collagen Dental MembraneSummary page 1…Class II 872.3930 LYC Predicate Device(s): Collagen Dental Membrane, K011695 Description of the Device Collagen Dental Membrane-Conformable II is a white, nonfriable, conformable, resorbable, membrane mat… | 2001 |
What descends from it? (7)
4 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 9 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K090216 (Collagen Matrix, Inc., 2009) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K011695.
How does its category compare?
All NPL devicesNPL Barrier, Animal Source, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 - Conformable II is intended for use in oral surgical procedures as a resorbable material for placement in the area of dental implant, bone defect, or ridge augmentation to aid in wound healing.
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/K062881 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062881: Collagen Dental Menbrane - Conformable II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062881
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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