510(k) · Cleared
Recalled · Class II · 2018Orthopantomograph OP 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Palodex Group OY · OAS X-Ray, Tomography, Computed, Dental
Cleared on Apr 7, 2017 as substantially equivalent to K133544 (Palodex Group OY, 2014) after a 21-day review. Its family tree reaches back 8 generations to 1997. It has been recalled once.
- Decided
- Apr 7, 2017
- Review
- 21 days
- Class
- Class II
- Product code
- OAS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K973598 (1997). 16 ancestors in all, the oldest K930338 (1993). No later device cites it as a predicate yet.
- Root · 8 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 7 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 6 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 5 generations backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- 4 generations backK073350 Scanora 3DSoredex Palodex Group OY · 2007
- 3 generations backK093683 Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010
- 2 generations backK122018 OP300Palodex Group OY · 2012
- 1 generation backK133544 OP300Palodex Group OY · 2014
- This deviceK170813 Orthopantomograph OP 3DPalodex Group OY · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −7 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −6 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −5 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| −4 | K073350 | Scanora 3D | Soredex Palodex Group OY | 2007 | — |
| −3 | K093683 | Orthopantomograph OP300 | Instrumentarium Dental, Palodex Group OY | 2010 | — |
| −2 | K122018 | OP300 | Palodex Group OY | 2012 | — |
| −1 | K133544 | OP300 | Palodex Group OY | 2014 | — |
| 0 (this device) | K170813 | Orthopantomograph OP 3D | Palodex Group OY | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K133544 | OP300Summary page 4…Device Class: II Product Code: OAS Predicate Device: Proprietary Name: ORTHOPANTOMOGRAPH™ OP300 510(k) Number K133544 Common Name: X-ray, Tomography, Computed, Dental Classification Name: Computed tomography x-ray system… | 2014 |
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 |
|---|---|---|---|---|
| Dec 31, 2018 | Class II | Z-1101-2019 | Device Design | ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1 |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 16 ancestors have a recall of any class.
- 3 other devices also cite its predicate K133544.
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. 2017, 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?
ORTHOPANTOMOGRAPH™ OP 3D is an x-ray device to take panoramic and 3D images of the cranio-maxillofacial complex for use in diagnostic support.
ORTHOPANTOMOGRAPH™ OP 3D must only be used and operated by dentist and other qualified professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170813 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170813: Orthopantomograph OP 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170813
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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