510(k) · Cleared
ClearedAongen Dental Collagen Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aeon Astron Europe B.V. · OLR Oral Wound Dressing
Cleared on Mar 1, 2012 as substantially equivalent to K073685 (Osseous Technologies of America, 2008) and 1 other predicate after a 177-day review. Its family tree reaches back 5 generations to 1988.
- Decided
- Mar 1, 2012
- Review
- 177 days
- Class
- Class U
- Product code
- OLR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K881854 (1988). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 4 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 3 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 2 generations backK021792 Bilayer Matrix Wound DressingIntegra Lifesciences Corp. · 2002 · Recalled
- 1 generation backK081635 Integra Meshed Bilayer Wound MatrixIntegra Lifesciences Corp. · 2008
- This deviceK112568 Aongen Dental Collagen MatrixAeon Astron Europe B.V. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −4 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −3 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −2 | K021792 | Bilayer Matrix Wound Dressing | Integra Lifesciences Corp. | 2002 | 1 |
| −1 | K081635 | Integra Meshed Bilayer Wound Matrix | Integra Lifesciences Corp. | 2008 | — |
| 0 (this device) | K112568 | Aongen Dental Collagen Matrix | Aeon Astron Europe B.V. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 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 OLR? 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 OLR device
- #1 K253758 Dental Cone; Dental Spongescore 13.2 · 10 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 |
|---|---|---|---|
| * | K073685 | Ota Collagen BiomaterialSummary page 1…e Device: Predicate #1 Proprietary Name: OTA Collagen Biomnaterial Common Name: Collagen dental membrane Product Code: NPL 5 10(k) Number: K073685 5 10(k) Submitter: Osseous Technologies of America, Inc. Predicate #2 Proprietary Name: Integra Meshed Bilayer Wound M… | 2008 |
| * | K081635 | Integra Meshed Bilayer Wound MatrixSummary page 1…s of America, Inc. Predicate #2 Proprietary Name: Integra Meshed Bilayer Wound Matrix Common Name: N/A Product Code: FRO 510(k) Number: K081635 5 10(k) Submitter: Integra Lifesciences Corp. Page 5-1… | 2008 |
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 24 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 14 ancestors has a recall of any class.
How does its category compare?
All OLR devicesOLR Oral Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OLR
4so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · OLR
83in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLR
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OLR
5in 2025
MAUDE reports naming product code OLR, 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 | 3 | 93 | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 3 | 115 | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 2 | — | 1 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 83 | 0 | 5 |
| 2026 | 4 | 188 | 0 | — |
What is it indicated for?
AongenTM Dental is intended for use in dental surgical procedures as a resorbable
material for open wounds to aid in wound healing post surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112568 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112568: Aongen Dental Collagen Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112568
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