510(k) · Cleared
ClearedDynaMatrix/Dynamatrix Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Biotech Incorporated · NPL Barrier, Animal Source, Intraoral
Cleared on Jan 13, 2017 as substantially equivalent to K082058 (Cook Biotech, Inc., 2008) after a 200-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Jan 13, 2017
- Review
- 200 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010952 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK010952 Surgisis Guided Tissue Regeneration MatrixCook Biotech, Inc. · 2002
- 1 generation backK082058 DynamatrixCook Biotech, Inc. · 2008
- This deviceK161762 DynaMatrix/Dynamatrix PlusCook Biotech Incorporated · 2017
- Descendant · cites it directly · 0 of its ownK231513 Oral MatrixBeijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K231513Oral MatrixBeijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010952 | Surgisis Guided Tissue Regeneration Matrix | Cook Biotech, Inc. | 2002 | — |
| −1 | K082058 | Dynamatrix | Cook Biotech, Inc. | 2008 | — |
| 0 (this device) | K161762 | DynaMatrix/Dynamatrix Plus | Cook Biotech Incorporated | 2017 | — |
| +1 | K231513 | Oral Matrix | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K082058 | DynamatrixSummary page 4…have been established under Section 514 of the Food, Drug and Cosmetic Act apply to this device. Predicate Device: The predicate device is DynaMatrix (K082058), cleared October 2, 2008. Reference Device: The reference device is Surgisis Periodontal Membrane (K010952), cleare… | 2008 |
| † | K010952 | Surgisis Guided Tissue Regeneration Matrix | 2002 |
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 |
|---|---|---|---|
| K231513 | Oral Matrix | 2024 | 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 15 years and passes through 2 companies; a new generation was cleared every 8.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K231513 (Beijing Biosis Healing Biolog Ical Technology Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K082058.
How does its category compare?
All NPL devicesNPL Barrier, Animal Source, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
DynaMatrix is intended for use in guided tissue regeneration and bone regeneration procedures. It may be used for bone regeneration and healing of periodontal defects, for gingival augmentation, to maintain or enhance alveolar ridges, or to contain or prevent migration of graft material. The device is supplied sterile and intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161762: DynaMatrix/Dynamatrix Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161762
Report an extraction error
Are you the manufacturer?
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