510(k) · Cleared
ClearedOrthopantomograph OP100D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentarium Corp. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Sep 28, 1999 after a 74-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 14 later devices descend from it.
- Decided
- Sep 28, 1999
- Review
- 74 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK992385 Orthopantomograph OP100DInstrumentarium Corp. · 1999
- Descendant · cites it directly · 10 of its ownK043612 Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200DInstrumentarium Corp. Imaging Division · 2005
- Descendant · 2 generations on · 6 of its ownK141700 Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2014
- Descendant · 3 generations on · 4 of its ownK150354 PAPAYA 3D PlusGenoray Co., Ltd. · 2015
- Descendant · 4 generations on · 1 of its ownK200469 PAPAYA 3D Premium & PAPAYA 3D Premium PlusGenoray Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK181297 DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp. · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K043612Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200DInstrumentarium Corp. Imaging Division · 2005 · cites it directly10descendants
- K141700Papaya Plus, Digital Extraoral Source X-Ray SystemGenoray Co., Ltd. · 2014 · 2 generations on6descendants
- K150354PAPAYA 3D PlusGenoray Co., Ltd. · 2015 · 3 generations on4descendants
- K200469PAPAYA 3D Premium & PAPAYA 3D Premium PlusGenoray Co., Ltd. · 2020 · 4 generations on1descendant
- K181297DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp. · 2018 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992385 | Orthopantomograph OP100D | Instrumentarium Corp. | 1999 | — |
| +1 | K043612 | Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200D | Instrumentarium Corp. Imaging Division | 2005 | — |
| +2 | K141700 | Papaya Plus, Digital Extraoral Source X-Ray System | Genoray Co., Ltd. | 2014 | — |
| +3 | K150354 | PAPAYA 3D Plus | Genoray Co., Ltd. | 2015 | — |
| +4 | K200469 | PAPAYA 3D Premium & PAPAYA 3D Premium Plus | Genoray Co., Ltd. | 2020 | — |
| +1 | K181297 | DENTIOIII series (DENTIOIII, DENTIOIII-S) | Hdx Will Corp. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 2 | 0 |
| 2025 | 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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (14)
See all 143 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, K043612 (Instrumentarium Corp. Imaging Division, 2005) has gone furthest, with 10 descendants of its own.
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.
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?
Orthopantomograph® OP100D is intended to be used for producing diagnostic x-ray radiographs of dentition, TM-joints and other oral structures.
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/K992385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992385: Orthopantomograph OP100D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992385
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