510(k) · Cleared
ClearedOrthophos Plus and Orthophos Plus/CD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pelton & Crane Co. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Sep 12, 1997 as substantially equivalent to K895467 (Siemens Medical Solutions USA, Inc., 1989) after an 88-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Sep 12, 1997
- Review
- 88 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K895467 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK895467 Orthophos and Orthophos CSiemens Medical Solutions USA, Inc. · 1989
- This deviceK972249 Orthophos Plus and Orthophos Plus/CDPelton & Crane Co. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895467 | Orthophos and Orthophos C | Siemens Medical Solutions USA, Inc. | 1989 | — |
| 0 (this device) | K972249 | Orthophos Plus and Orthophos Plus/CD | Pelton & Crane Co. | 1997 | — |
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? (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 |
|---|---|---|---|
| * | K895467 | Orthophos and Orthophos CSummary page 2…or Substantial Equivalence The Orthophos Plus and Orthophos Plus/CD are substantially equivalent to the Orthophos and Orthophos C which were cleared for marketing under K895467. The Orthophos Plus is a revised version of the Orthophos and differs from the Orthophos as follows: 1) Eleven additional progr… | 1989 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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 Orthophos Plus and Orthophos Plus/CD are intended to produce X-rays for
dental radiographic examination and diagnosis of diseases of the teeth, jaw, and
oral structures. The X-ray source is located outside the mouth. The system
provides for panoramic imaging of the entire maxillofacial region as well as
transverse slice imaging of the maxillary and mandibular regions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972249 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972249: Orthophos Plus and Orthophos Plus/CD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972249
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