510(k) · Cleared
ClearedOrthopantomograph OP300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentarium Dental, Palodex Group OY · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Oct 6, 2010 as substantially equivalent to K060328 (Planmeca Oy, 2006) and 2 other predicates after a 310-day review. Its family tree reaches back 5 generations to 1997. 21 later devices descend from it.
- Decided
- Oct 6, 2010
- Review
- 310 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K973598 (1997). 13 ancestors in all, the oldest K930338 (1993). 21 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 4 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 3 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 2 generations backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- 1 generation backK073350 Scanora 3DSoredex Palodex Group OY · 2007
- This deviceK093683 Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010
- Descendant · cites it directly · 11 of its ownK111231 Panoura 18SThe Yoshida Dental Mfg. Co., Ltd. · 2011
- Descendant · cites it directly · 8 of its ownK122018 OP300Palodex Group OY · 2012
- Descendant · 2 generations on · 7 of its ownK133544 OP300Palodex Group OY · 2014
- Descendant · 2 generations on · 6 of its ownK122199 PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd. · 2013
- Descendant · 3 generations on · 2 of its ownK180947 Orthopantomograph OP 3DPalodex Group OY · 2018 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K111231Panoura 18SThe Yoshida Dental Mfg. Co., Ltd. · 2011 · cites it directly11descendants
- K122018OP300Palodex Group OY · 2012 · cites it directly8descendants
- K133544OP300Palodex Group OY · 2014 · 2 generations on7descendants
- K122199PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd. · 2013 · 2 generations on6descendants
- K180947Orthopantomograph OP 3DPalodex Group OY · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −4 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −3 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −2 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| −1 | K073350 | Scanora 3D | Soredex Palodex Group OY | 2007 | — |
| 0 (this device) | K093683 | Orthopantomograph OP300 | Instrumentarium Dental, Palodex Group OY | 2010 | — |
| +1 | K111231 | Panoura 18S | The Yoshida Dental Mfg. Co., Ltd. | 2011 | — |
| +1 | K122018 | OP300 | Palodex Group OY | 2012 | — |
| +2 | K133544 | OP300 | Palodex Group OY | 2014 | — |
| +2 | K122199 | PREXION3D Eclipse | The Yoshida Dental Mfg. Co., Ltd. | 2013 | — |
| +3 | K180947 | Orthopantomograph OP 3D | Palodex Group OY | 2018 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 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 MUH? 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 MUH device
- #1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K060328 | Planmeca Promax 3DSummary page 1…e Classification name: System, x-ray, extraoral source, digital (21 CFR 872.1800, product code MUH) Predicate device: Planmeca Promax 3D (K060328), SCANORA® 3D (K073350) and Veraviewepacs 3D (K073696). Description: Orthopantomograph 0P300 isan extraoral source d… | 2006 |
| * | K073350 | Scanora 3DSummary page 1…System, x-ray, extraoral source, digital (21 CFR 872.1800, product code MUH) Predicate device: Planmeca Promax 3D (K060328), SCANORA® 3D (K073350) and Veraviewepacs 3D (K073696). Description: Orthopantomograph 0P300 isan extraoral source dental x-ray device, whi… | 2007 |
| * | K073696 | VeraviewepocsSummary page 1…l source, digital (21 CFR 872.1800, product code MUH) Predicate device: Planmeca Promax 3D (K060328), SCANORA® 3D (K073350) and Veraviewepacs 3D (K073696). Description: Orthopantomograph 0P300 isan extraoral source dental x-ray device, which produces conventional… | 2008 |
What descends from it? (21)
See all 213 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K111231 (The Yoshida Dental Mfg. Co., Ltd., 2011) has gone furthest, with 11 descendants of its own.
- 6 other devices also cite its predicate K060328.
How does its category compare?
All MUH devicesMUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MUH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUH
159in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUH
1in 2025
MAUDE reports naming product code MUH, 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 | 11 | 48 | 0 | 0 |
| 2008 | 8 | 64 | 1 | 0 |
| 2009 | 9 | 88 | 2 | 12 |
| 2010 | 9 | 174 | 0 | 9 |
| 2011 | 10 | 89 | 0 | 0 |
| 2012 | 9 | 81 | 0 | 5 |
| 2013 | 9 | 172 | 1 | 1 |
| 2014 | 8 | 168 | 1 | 5 |
| 2015 | 12 | 111 | 1 | 3 |
| 2016 | 6 | 47 | 0 | 1 |
| 2017 | 9 | 84 | 0 | 4 |
| 2018 | 3 | 29 | 0 | 10 |
| 2019 | 5 | 64 | 0 | 6 |
| 2020 | 5 | 36 | 0 | 0 |
| 2021 | 10 | 80 | 0 | 1 |
| 2022 | 7 | 57 | 0 | 0 |
| 2023 | 11 | 57 | 0 | 1 |
| 2024 | 4 | 144 | 0 | 0 |
| 2025 | 3 | 159 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Orthopantomograph® 0P300 dental panoramic, cephalometric and cone beam computed tomography x-ray device is intended for dental radiographic examinations of teeth, jaw and TMJ areas by producing conventional 2D x-ray images as well as x-ray projection images of an examined volume for the reconstruction of a 3D view. The device must only be operated and used by dentists and other legally qualified professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093683: Orthopantomograph OP300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093683
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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