510(k) · Cleared
ClearedPlanmeca Promax 3D Max
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Planmeca Oy · MUH System, X-Ray, Extraoral Source, Digital
Cleared on May 12, 2010 as substantially equivalent to K060328 (Planmeca Oy, 2006) after a 174-day review. Its family tree reaches back 4 generations to 1997. 15 later devices descend from it.
- Decided
- May 12, 2010
- Review
- 174 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K973598 (1997). 6 ancestors in all. 15 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 3 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 2 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 1 generation backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- This deviceK093590 Planmeca Promax 3D MaxPlanmeca Oy · 2010
- Descendant · cites it directly · 9 of its ownK160140 DENTRIa seriesHdx Will Corp. · 2016
- Descendant · cites it directly · 7 of its ownK160506 Planmeca ProMax 3D Max, Planmeca MaximityPlanmeca Oy · 2016
- Descendant · 2 generations on · 4 of its ownK181576 Planmeca VisoPlanmeca Oy · 2018
- Descendant · 2 generations on · 3 of its ownK230985 Planmeca VisoPlanmeca Oy · 2023
- Descendant · 3 generations on · 1 of its ownK251842 Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd. · 2025
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K160140DENTRIa seriesHdx Will Corp. · 2016 · cites it directly9descendants
- K160506Planmeca ProMax 3D Max, Planmeca MaximityPlanmeca Oy · 2016 · cites it directly7descendants
- K181576Planmeca VisoPlanmeca Oy · 2018 · 2 generations on4descendants
- K230985Planmeca VisoPlanmeca Oy · 2023 · 2 generations on3descendants
- K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd. · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −3 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −2 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −1 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| 0 (this device) | K093590 | Planmeca Promax 3D Max | Planmeca Oy | 2010 | — |
| +1 | K160140 | DENTRIa series | Hdx Will Corp. | 2016 | — |
| +1 | K160506 | Planmeca ProMax 3D Max, Planmeca Maximity | Planmeca Oy | 2016 | — |
| +2 | K181576 | Planmeca Viso | Planmeca Oy | 2018 | — |
| +2 | K230985 | Planmeca Viso | Planmeca Oy | 2023 | — |
| +3 | K251842 | Dental Computed Tomography X-ray System | Fussen Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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? (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 |
|---|---|---|---|
| * | K060328 | Planmeca Promax 3DSummary page 2…this product modification to be similar in design, composition and function to the following device introduced into commercial distribution after May 28, 1976: #tK060328 Planmeca ProMax 3D The comparison of characteristics SUPports substantial equivalence. Planmneca Promax 3D Max is as safe a… | 2006 |
What descends from it? (15)
See all 154 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 3 companies; a new generation was cleared every 4.2 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K160140 (Hdx Will Corp., 2016) has gone furthest, with 9 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?
Planmeca Promax 3D Max, is a three dimensional Cone Beam Volumetric Tomography (CBVT) x-ray system, which is intended to produce three-dimensional images of the human teeth, jaw and skull. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. The device is to be operated and used by dentists and other legally qualified health care professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093590: Planmeca Promax 3D Max.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093590
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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