510(k) · Cleared
ClearedPM 2002 CC Proline
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 Aug 5, 1997 after a 153-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Aug 5, 1997
- Review
- 153 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK970812 PM 2002 CC ProlinePlanmeca Oy · 1997
- Descendant · cites it directly · 4 of its ownK040748 Ana-Bel, Model 087D and Ana-Bel CM, Model 187-CMTakara Belmont USA, Inc. · 2004
- Descendant · 2 generations on · 2 of its ownK090020 Bel-Cypher, Model Y977Takara-Belmont Co., Ltd. · 2009
- Descendant · 3 generations on · 1 of its ownK110160 Bel-Cypher NTakara Belmont Corporation · 2011
- Descendant · 4 generations on · 0 of its ownK163175 Bel-Cypher ProTakara Belmont Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK062529 Belmax CM Model X168Takara Belmont USA, Inc. · 2006
Most influential descendants
Showing 5 of 5 · See all- K040748Ana-Bel, Model 087D and Ana-Bel CM, Model 187-CMTakara Belmont USA, Inc. · 2004 · cites it directly4descendants
- K090020Bel-Cypher, Model Y977Takara-Belmont Co., Ltd. · 2009 · 2 generations on2descendants
- K110160Bel-Cypher NTakara Belmont Corporation · 2011 · 3 generations on1descendant
- K163175Bel-Cypher ProTakara Belmont Corporation · 2017 · 4 generations on0descendants
- K062529Belmax CM Model X168Takara Belmont USA, Inc. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970812 | PM 2002 CC Proline | Planmeca Oy | 1997 | — |
| +1 | K040748 | Ana-Bel, Model 087D and Ana-Bel CM, Model 187-CM | Takara Belmont USA, Inc. | 2004 | — |
| +2 | K090020 | Bel-Cypher, Model Y977 | Takara-Belmont Co., Ltd. | 2009 | — |
| +3 | K110160 | Bel-Cypher N | Takara Belmont Corporation | 2011 | — |
| +4 | K163175 | Bel-Cypher Pro | Takara Belmont Corporation | 2017 | — |
| +2 | K062529 | Belmax CM Model X168 | Takara Belmont USA, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040748 | Ana-Bel, Model 087D and Ana-Bel CM, Model 187-CM | 2004 | 4 |
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?
- Of its descendants, K040748 (Takara Belmont USA, Inc., 2004) has gone furthest, with 4 descendants of its own.
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?
The Planmeca Dimax Digital Panoramic X-ray Unit 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. This device is a multimode imaging system, which combines following imaging procedures:
Narrow beam tomography (= panoramic mode)
Cephalometric radiography
The use of the device is allowed only under supervision of a dentist.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970812 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970812: PM 2002 CC Proline.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970812
Report an extraction error
Are you the manufacturer?
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