510(k) · Cleared
ClearedColladental Barrier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Collamatrix, Inc. · NPL Barrier, Animal Source, Intraoral
Cleared on Jan 3, 2013 as substantially equivalent to K992216 (Integra Lifesciences Corp., 1999) and 1 other predicate after a 1,029-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Jan 3, 2013
- Review
- 1,029 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K924408 (1995). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK924408 Colla-Tec Absorbable Collagen MembraneColla-Tec, Inc. · 1995 · Recalled
- 2 generations backK992216 Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable…Integra Lifesciences Corp. · 1999 · Recalled
- 1 generation backK042197 Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone…Ed. Geistlich Soehne AG Fuer Chemische Industrie · 2004
- This deviceK100695 Colladental BarrierCollamatrix, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK133507 GuidossNibec Co., Ltd. · 2014
Most influential descendants
Showing 1 of 1 · See all- K133507GuidossNibec Co., Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924408 | Colla-Tec Absorbable Collagen Membrane | Colla-Tec, Inc. | 1995 | 2 |
| −2 | K992216 | Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen… | Integra Lifesciences Corp. | 1999 | 1 |
| −1 | K042197 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration | Ed. Geistlich Soehne AG Fuer Chemische Industrie | 2004 | — |
| 0 (this device) | K100695 | Colladental Barrier | Collamatrix, Inc. | 2013 | — |
| +1 | K133507 | Guidoss | Nibec Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 |
|---|---|---|---|
| * | K992216 | Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen MenbraneSummary page 2…agency. CollaDental Barrier is substantially equivalent in indications and design principles to predicate devices, BioMend Extend absorbable collagen membrane (K9922 16) and BIQ-GTDE@8 (1(042197), each of which has been determined by FDA to be substantially equivalent to. preamendment devices… | 1999 |
| * | K042197 | Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone RegenerationSummary page 2…is substantially equivalent in indications and design principles to predicate devices, BioMend Extend absorbable collagen membrane (K9922 16) and BIQ-GTDE@8 (1(042197), each of which has been determined by FDA to be substantially equivalent to. preamendment devices. CollaDental Barrier has.… | 2004 |
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 |
|---|---|---|---|
| K133507 | Guidoss | 2014 | 0 |
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 18 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K133507 (Nibec Co., Ltd., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K992216.
How does its category compare?
All NPL devicesNPL Barrier, Animal Source, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
CollaDental Barrier is intended for use in oral surgical procedures including use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; filling of bone defects after roots resection, cystectomy, removal of retained teeth; guided bone regeneration in dental implant associated bony dehiscence defects and guided tissue regeneration procedures in bony dehiscence defects around teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100695: Colladental Barrier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100695
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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