510(k) · Cleared

Recalled · Class II · 2019

Collagen Dental Membrane

K011695510(k) TraditionalCleared Aug 7, 200168-day reviewClass II21 CFR 872.3930Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Collagen Matrix, Inc. · NPL Barrier, Animal Source, Intraoral

Cleared on Aug 7, 2001 as substantially equivalent to K960724 (Geistlich-Pharma, 1997) after a 68-day review. Its family tree reaches back 1 generation to 1997. 15 later devices descend from it. It has been recalled once.

Decided: Aug 7, 2001
Review: 68 days
Class: Class II
Product code: NPL
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K960724 (1997). 15 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK960724 Bio-Gide Resorbable Bilayer MembraneGeistlich-Pharma · 1997
This deviceK011695 Collagen Dental MembraneCollagen Matrix, Inc. · 2001
Descendant · cites it directly · 7 of its ownK062881 Collagen Dental Menbrane - Conformable IICollagen Matrix, Inc. · 2006
Descendant · 2 generations on · 3 of its ownK090216 Collagen Dental Membrane IVCollagen Matrix, Inc. · 2009
Descendant · cites it directly · 3 of its ownK051267 Gore Resolut Regenerative Material, Gore Resolut XT Regenerative…W. L. Gore & Associates, Inc. · 2005
Descendant · 3 generations on · 1 of its ownK100156 Collagen Dental Membrane VCollagen Matrix, Inc. · 2010 · Recalled
Descendant · 2 generations on · 1 of its ownK091120 Medpor Contain ImplantPorex Surgical, Inc. · 2010

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2004high 3 (2009) · low 0 (2007)2026

Most influential descendants

Showing 5 of 15 · See all

K062881Collagen Dental Menbrane - Conformable IICollagen Matrix, Inc. · 2006 · cites it directly7descendants
K090216Collagen Dental Membrane IVCollagen Matrix, Inc. · 2009 · 2 generations on3descendants
K051267Gore Resolut Regenerative Material, Gore Resolut XT Regenerative Membrane, Gore…W. L. Gore & Associates, Inc. · 2005 · cites it directly3descendants
K100156Collagen Dental Membrane VCollagen Matrix, Inc. · 2010 · 3 generations on1descendant
K091120Medpor Contain ImplantPorex Surgical, Inc. · 2010 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K960724	Bio-Gide Resorbable Bilayer Membrane	Geistlich-Pharma	1997	—
0 (this device)	K011695	Collagen Dental Membrane	Collagen Matrix, Inc.	2001	—
+1	K062881	Collagen Dental Menbrane - Conformable II	Collagen Matrix, Inc.	2006	—
+2	K090216	Collagen Dental Membrane IV	Collagen Matrix, Inc.	2009	—
+1	K051267	Gore Resolut Regenerative Material, Gore Resolut XT Regenerative Membrane…	W. L. Gore & Associates, Inc.	2005	—
+3	K100156	Collagen Dental Membrane V	Collagen Matrix, Inc.	2010	6
+2	K091120	Medpor Contain Implant	Porex Surgical, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	2	0
2006	2	0
2009	3	0
2010	2	0
2011	2	0
2013	1	0
2014	2	0

FIG. 1 — Lineage of K011695, 1997–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K960724	Bio-Gide Resorbable Bilayer Membrane Summary page 1 …sident & CEO Tel: (201) 405-1477 Date of summary: May 24, 2001 Device generic name: Collagen Dental Membrane Device trade name: None Predicate device: BioGide®, [510(k) #K960724] Description of the device: The Collagen Dental Membrane is a resorbable, type I collagen matrix of defined geometry, in vivo st…	Geistlich-Pharma	1997	—

Also cleared against K960724: 10 other devices →

What descends from it? (15)

See all 15

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K062881	Collagen Dental Menbrane - Conformable II	Collagen Matrix, Inc.	2006	7
K051267	Gore Resolut Regenerative Material, Gore Resolut XT Regenerative Membrane, Gore…	W. L. Gore & Associates, Inc.	2005	3
K062846	Collagen Dental Membrane Iii	Collagen Matrix, Inc.	2006	0
K052041	Collagen Bone Healing Protective Sheet	Collagen Matrix, Inc.	2005	0
K033729	Collagen Dental Wound Dressings	Collagen Matrix, Inc.	2004	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 19, 2019	Class II	Z-1389-2019	Under Investigation by firm	Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K062881 (Collagen Matrix, Inc., 2006) has gone furthest, with 7 descendants of its own.
10 other devices also cite its predicate K960724.

How does its category compare?

All NPL devices

NPL Barrier, Animal Source, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NPL

5in 2025

2007high 5 (2014) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NPL

132in 2025

2007high 290 (2022) · low 132 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NPL

6in 2019

2007high 6 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NPL

39in 2025

2007high 39 (2025) · low 0 (2007)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 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 post surgery.

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/K011695 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011695: Collagen Dental Membrane.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011695

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026