510(k) · Cleared
ClearedOrthoceph OC100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentarium Corp. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Apr 27, 1993 after a 92-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 26 later devices descend from it.
- Decided
- Apr 27, 1993
- Review
- 92 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 0
26 later devices descend from it, 2 citing it directly.
- This deviceK930338 Orthoceph OC100Instrumentarium Corp. · 1993
- Descendant · cites it directly · 24 of its ownK030699 Veraviewepocs Panoramic/Cephalometric X-Ray Unit with CephalometricJ. Morita Mfg. Corp. · 2003
- Descendant · 2 generations on · 22 of its ownK073696 VeraviewepocsJ. Morita USA, Inc. · 2008
- Descendant · 3 generations on · 21 of its ownK093683 Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010
- Descendant · 4 generations on · 11 of its ownK111231 Panoura 18SThe Yoshida Dental Mfg. Co., Ltd. · 2011
- Descendant · 4 generations on · 8 of its ownK122018 OP300Palodex Group OY · 2012
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K030699Veraviewepocs Panoramic/Cephalometric X-Ray Unit with CephalometricJ. Morita Mfg. Corp. · 2003 · cites it directly24descendants
- K073696VeraviewepocsJ. Morita USA, Inc. · 2008 · 2 generations on22descendants
- K093683Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010 · 3 generations on21descendants
- K111231Panoura 18SThe Yoshida Dental Mfg. Co., Ltd. · 2011 · 4 generations on11descendants
- K122018OP300Palodex Group OY · 2012 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K930338 | Orthoceph OC100 | Instrumentarium Corp. | 1993 | — |
| +1 | K030699 | Veraviewepocs Panoramic/Cephalometric X-Ray Unit with Cephalometric | J. Morita Mfg. Corp. | 2003 | — |
| +2 | K073696 | Veraviewepocs | J. Morita USA, Inc. | 2008 | — |
| +3 | K093683 | Orthopantomograph OP300 | Instrumentarium Dental, Palodex Group OY | 2010 | — |
| +4 | K111231 | Panoura 18S | The Yoshida Dental Mfg. Co., Ltd. | 2011 | — |
| +4 | K122018 | OP300 | Palodex Group OY | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 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), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (26)
See all 262 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?
- Of its descendants, K030699 (J. Morita Mfg. Corp., 2003) has gone furthest, with 24 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 | — |
https://510kreport.com/device/K930338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K930338: Orthoceph OC100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930338
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026