510(k) · Cleared
ClearedOral Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · NPL Barrier, Animal Source, Intraoral
Cleared on Feb 16, 2024 as substantially equivalent to K161762 (Cook Biotech Incorporated, 2017) after a 267-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Feb 16, 2024
- Review
- 267 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010952 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK010952 Surgisis Guided Tissue Regeneration MatrixCook Biotech, Inc. · 2002
- 2 generations backK082058 DynamatrixCook Biotech, Inc. · 2008
- 1 generation backK161762 DynaMatrix/Dynamatrix PlusCook Biotech Incorporated · 2017
- This deviceK231513 Oral MatrixBeijing Biosis Healing Biolog Ical Technology Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010952 | Surgisis Guided Tissue Regeneration Matrix | Cook Biotech, Inc. | 2002 | — |
| −2 | K082058 | Dynamatrix | Cook Biotech, Inc. | 2008 | — |
| −1 | K161762 | DynaMatrix/Dynamatrix Plus | Cook Biotech Incorporated | 2017 | — |
| 0 (this device) | K231513 | Oral Matrix | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2024 | — |
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 |
|---|---|---|---|
| * | K161762 | DynaMatrix/Dynamatrix PlusSummary page 7…SIS-ORP-4L-6×8 6×8 SIS-ORP-4L-8×8 8×8 5. Identification of Predicate Device 510(k) Number: K161762 Product Name: Dynamatrix/dynamatrix Plus 6. Non-Clinical Test Conclusion Following non-clinical tests were… | 2017 |
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 22 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All NPL devicesNPL Barrier, Animal Source, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
The Oral Matrix is intended for use in extraction sockets only 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/K231513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231513: Oral Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231513
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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