510(k) · Cleared
ClearedOrthophos S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Sirona · OAS X-Ray, Tomography, Computed, Dental
Cleared on Jul 16, 2019 as substantially equivalent to K150217 (Sirona Dental Systems GmbH, 2015) after a 28-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Jul 16, 2019
- Review
- 28 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 deviceK191616 Orthophos SDentsply Sirona · 2019
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) | K191616 | Orthophos S | Dentsply Sirona | 2019 | — |
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 22 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. 2019, 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?
The X-ray system creates data for digital exposures in the maxillofacial area and in subareas for dentistry and pediatric
dentistry, for hard-tissue diagnostics within ENT medicine, and carpus exposures.
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/K191616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191616: Orthophos S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191616
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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