PMA · Approved
Recalled · Class II · 2025Biora Emdogain (R)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Straumann Company · NQA Biologic Material, Dental
Approved on Sep 30, 1996 through premarket approval, which rests on the device’s own clinical evidence after a 1,169-day review. It has been recalled 7 times.
- Decided
- Sep 30, 1996
- Review
- 1,169 days
- Class
- Class III
- Product code
- NQA
- Recalls
- 7
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P930021 has 34 supplements since 1999: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1999 | 3 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 3 |
| 2006 | 1 |
| 2007 | 1 |
| 2009 | 2 |
| 2013 | 1 |
| 2015 | 2 |
| 2017 | 2 |
| 2018 | 3 |
| 2019 | 4 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 4 |
| 2025 | 2 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NQA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 17, 2025 | Class II | Z-0582-2026 | Under Investigation by firm | The possibility for this product that is intended for demonstration purposes only to be placed in patients. |
| Mar 23, 2018 | Class II | Z-1694-2018 | Component change control | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product. |
| Mar 23, 2018 | Class II | Z-1693-2018 | Component change control | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product. |
| Mar 23, 2018 | Class II | Z-1697-2018 | Component change control | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product. |
| Mar 23, 2018 | Class II | Z-1696-2018 | Component change control | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product. |
| Mar 23, 2018 | Class II | Z-1698-2018 | Component change control | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product. |
| Mar 23, 2018 | Class II | Z-1695-2018 | Component change control | A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NQA devicesNQA Biologic Material, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NQA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NQA
Too few NQA 510(k)s in any year since 2007 to give a median.
Recalls per year · NQA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQA
2in 2015
MAUDE reports naming product code NQA, 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 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 4 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | — | 0 | 0 |
| 2019 | 4 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 4 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 2 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P930021 · printed Nov 6, 2026
Cite this page
510(k) Report. “P930021: Biora Emdogain (R).” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P930021
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026