510(k) · Cleared
ClearedStellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fona S.R.L · OAS X-Ray, Tomography, Computed, Dental
Cleared on Mar 2, 2022 as substantially equivalent to K150217 (Sirona Dental Systems GmbH, 2015) after a 112-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Mar 2, 2022
- Review
- 112 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K973642 (1997). 17 ancestors in all, the oldest K972312 (1997). No later device cites it as a predicate yet.
- Root · 8 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 7 generations backK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- 6 generations backK082350 PAX-500VATECH Co., Ltd. · 2008
- 5 generations backK090171 Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009
- 4 generations backK102124 Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2010
- 3 generations backK120263 Volux 21C, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2012
- 2 generations backK123070 Galileos FamilySirona Dental Systems GmbH · 2013
- 1 generation backK150217 Orthophos SLSirona Dental Systems GmbH · 2015
- This deviceK213579 Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D CephFona S.R.L · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| −7 | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| −6 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| −5 | K090171 | Computed Tomography X-Ray System, Pax-REVE3D | E-Woo Technology | 2009 | — |
| −4 | K102124 | Dental Computed Tomography X-Ray System | VATECH Co., Ltd. | 2010 | — |
| −3 | K120263 | Volux 21C, Digital Extraoral Source X-Ray System | Genoray Co., Ltd. | 2012 | — |
| −2 | K123070 | Galileos Family | Sirona Dental Systems GmbH | 2013 | — |
| −1 | K150217 | Orthophos SL | Sirona Dental Systems GmbH | 2015 | — |
| 0 (this device) | K213579 | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph | Fona S.R.L | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 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 OAS? 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 OAS device
- #1 K213226 RCT700score 18.0 · 13 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.
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 25 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- None of the 17 ancestors has a recall.
- 3 other devices also cite its predicate K150217.
How does its category compare?
All OAS devicesOAS X-Ray, Tomography, Computed, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OAS
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAS
144in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAS
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAS
1in 2025
MAUDE reports naming product code OAS, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 6 | 168 | 0 | 0 |
| 2012 | 7 | 110 | 0 | 0 |
| 2013 | 10 | 155 | 0 | 0 |
| 2014 | 5 | 170 | 0 | 0 |
| 2015 | 5 | 164 | 1 | 0 |
| 2016 | 12 | 154 | 0 | 0 |
| 2017 | 4 | 209 | 0 | 0 |
| 2018 | 11 | 57 | 0 | 0 |
| 2019 | 7 | 55 | 0 | 1 |
| 2020 | 9 | 113 | 0 | 0 |
| 2021 | 11 | 92 | 0 | 0 |
| 2022 | 6 | 105 | 0 | 1 |
| 2023 | 12 | 77 | 0 | 1 |
| 2024 | 4 | 129 | 0 | 2 |
| 2025 | 9 | 144 | 3 | 1 |
| 2026 | 9 | 77 | 0 | — |
What is it indicated for?
Stellaris 2D: Extraoral source dental X-ray system intended to perform panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry. Stellaris 2D Ceph: Extraoral source dental X-ray system intended to perform panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry, as…
Read the full statement (143 words)
Stellaris 2D: Extraoral source dental X-ray system intended to perform panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry.
Stellaris 2D Ceph: Extraoral source dental X-ray system intended to perform panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations.
Stellaris 3D: Extraoral source dental X-ray system intended to perform 3D and panoramic exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry.
Stellaris 3D Ceph: Extraoral source dental X-ray system intended to perform 3D, panoramic and cephalometric exams with production of diagnostic images in the dento-maxillo-facial region and in subregions, for general and pediatric dentistry, as well as carpal images for dental clinical investigations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213579 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213579: Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213579
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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