510(k) · Cleared
ClearedOSSIX Breeze
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datum Dental, Ltd. · NPL Barrier, Animal Source, Intraoral
Cleared on Jul 18, 2022 as substantially equivalent to K160281 (Datum Dental, Ltd., 2016) after a 343-day review. Its family tree reaches back 2 generations to 2006.
- Decided
- Jul 18, 2022
- Review
- 343 days
- Class
- Class II
- Product code
- NPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K053260 (2006). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K160281 | Ossix PlusSummary page 4…me: Barrier, animal source, intraoral (21 CFR 872.3930) Regulatory class: II Product code: NPL III. Predicate Device Primary predicate: OSSIX® Plus (K160281) Reference device: Straumann® Jason® Membrane (K173562) IV. Device Description OSSIX® Breeze cross-linked pericardium membrane… | 2016 |
| † | K173562 | Straumann Jason Membrane | 2018 |
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 16 years and passes through 2 companies; a new generation was cleared every 10.4 years on median.
- None of the 2 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. 2022, 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?
OSSIX® Breeze membrane alone or in combination with suitable augmentation materials (like autologous bone or other bone replacement materials) is indicated for immediate or delayed guided bone regeneration (GBR) and guided tissue regeneration (GTR) as a biodegradable membrane for:
1) Alveolar ridge augmentation and reconstruction,
2) Alveolar ridge preservation consequent to tooth extractions,
3) Over the window in sinus elevation procedures and for support of the Schneiderian membrane,
4) In intra bony defects around teeth,
5) Guided tissue regeneration procedures in periodontal defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212509 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212509: OSSIX Breeze.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212509
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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