510(k) · Cleared
ClearedCollagen Dental Membrane - Conformable PP
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 Nov 5, 2014 as substantially equivalent to K042197 (Ed. Geistlich Soehne AG Fuer Chemische Industrie, 2004) and 1 other predicate after a 113-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Nov 5, 2014
- Review
- 113 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K924408 (1995). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK924408 Colla-Tec Absorbable Collagen MembraneColla-Tec, Inc. · 1995 · Recalled
- 5 generations backK992216 Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable…Integra Lifesciences Corp. · 1999 · Recalled
- 4 generations backK042197 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone…Ed. Geistlich Soehne AG Fuer Chemische Industrie · 2004
- 3 generations backK050446 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and BoneEd. Geistlich Soehne AG Fuer Chemische Industrie · 2005
- 2 generations backK090216 Collagen Dental Membrane IVCollagen Matrix, Inc. · 2009
- 1 generation backK100156 Collagen Dental Membrane VCollagen Matrix, Inc. · 2010 · Recalled
- This deviceK141909 Collagen Dental Membrane - Conformable PPCollagen Matrix, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924408 | Colla-Tec Absorbable Collagen Membrane | Colla-Tec, Inc. | 1995 | 2 |
| −5 | K992216 | Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen… | Integra Lifesciences Corp. | 1999 | 1 |
| −4 | K042197 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2004 | — |
| −3 | K050446 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2005 | — |
| −2 | K090216 | Collagen Dental Membrane IV | Collagen Matrix, Inc. | 2009 | — |
| −1 | K100156 | Collagen Dental Membrane V | Collagen Matrix, Inc. | 2010 | 6 |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K042197 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone RegenerationSummary page 4…Class II 3. Legally Marketed Devices to Which Substantial Equivalence is Claimed Predicate Device(s): BIO-GIDE® K042197 Collagen Dental Membrane V K100156 4. Description of the… | 2004 |
| * | K100156 | Collagen Dental Membrane VSummary page 4…ice(s): BIO-GIDE® K042197 Collagen Dental Membrane V K100156 4. Description of the Device Collagen Dental Membrane – Conformable PP is a white, nonfriable, resorbable, single layered… | 2010 |
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 19 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 4 of the 10 ancestors have a recall of any class.
- 11 other devices also cite its predicate K042197.
How does its category compare?
All NPL devicesNPL Barrier, Animal Source, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 - Conformable PP is intended for use in oral surgical procedures as a resorbable membrane material for use in:
Simultaneous use of GBR-membrane and implants
Augmentation around implants placed in immediate extraction sockets
Augmentation around implants in delayed extraction sockets
Localized ridge augmentation for later implantation
Alveolar ridge reconstruction for prosthetic treatment
Filling of bone defects after root resection, cystectomy or removal of retained teeth
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/K141909 · printed Nov 5, 2026
Cite this page
510(k) Report. “K141909: Collagen Dental Membrane - Conformable PP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K141909
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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