510(k) · Cleared
ClearedPlanmeca Promax with Dec (Dynamic Exposure Control)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Planmeca Oy · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Jun 24, 2005 as substantially equivalent to K011619 (Planmeca Oy, 2001) and 1 other predicate after a 21-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Jun 24, 2005
- Review
- 21 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000163 (2000). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K072244Planmeca ProonePlanmeca Oy · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000163 | PM 2002 Proline/Aec | Planmeca Oy | 2000 | — |
| 0 (this device) | K051464 | Planmeca Promax with Dec (Dynamic Exposure Control) | Planmeca Oy | 2005 | — |
| +1 | K072244 | Planmeca Proone | Planmeca Oy | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 EHD? 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 EHD device
- #1 K260795 Hand-held Dental X-ray System (HyperLight-M)score 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K011619 | Promax, Panoramic X-Ray Unit with CephalostatSummary page 2…Exposure Control) system to be similar in design, composition and function to the following devices introduced into commercial distribution after May 28, 1976: # K01 1619 Planmeca Promax #fK000163 PM 2002 Proline with AEC The comparison of characteristics supports substantial equiva… | 2001 |
| * | K000163 | PM 2002 Proline/AecSummary page 2…in design, composition and function to the following devices introduced into commercial distribution after May 28, 1976: # K01 1619 Planmeca Promax #fK000163 PM 2002 Proline with AEC The comparison of characteristics supports substantial equivalence. Planmeca Promax with DEC is as… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072244 | Planmeca Proone | 2007 | 0 |
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?
How does its category compare?
All EHD devicesEHD Unit, X-Ray, Extraoral With Timer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EHD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EHD
58in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EHD
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EHD
6in 2024
MAUDE reports naming product code EHD, 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 | 1 | — | 0 | 5 |
| 2008 | 5 | 49 | 0 | 6 |
| 2009 | 4 | 92 | 0 | 38 |
| 2010 | 4 | 268 | 3 | 47 |
| 2011 | 3 | 102 | 3 | 26 |
| 2012 | 2 | — | 0 | 22 |
| 2013 | 4 | 216 | 0 | 21 |
| 2014 | 3 | 107 | 1 | 20 |
| 2015 | 1 | — | 0 | 110 |
| 2016 | 2 | — | 1 | 63 |
| 2017 | 4 | 28 | 1 | 66 |
| 2018 | 5 | 30 | 0 | 21 |
| 2019 | 4 | 173 | 0 | 21 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 8 | 58 | 0 | 4 |
| 2023 | 8 | 147 | 0 | 2 |
| 2024 | 7 | 58 | 0 | 6 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 6 | 128 | 0 | — |
What is it indicated for?
Planmeca Promax, panoramic x-ray imaging system with Cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device can be equipped with accessories to fulfil different diagnostic needs. In digital configuration the images are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051464 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051464: Planmeca Promax with Dec (Dynamic Exposure Control).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051464
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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