510(k) · Cleared
ClearedDENTIOIII series (DENTIOIII, DENTIOIII-S)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hdx Will Corp. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Nov 21, 2018 as substantially equivalent to K142058 (Ray Co., Ltd., 2015) and 2 other predicates after a 189-day review. Its family tree reaches back 9 generations to 1997. 1 later device descends from it.
- Decided
- Nov 21, 2018
- Review
- 189 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K973598 (1997). 28 ancestors in all, the oldest K961826 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations between
- 3 generations backK131695 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- 2 generations backK142247 Rayscan a-Expert 3DRay Co., Ltd. · 2015
- 1 generation backK160140 DENTRIa seriesHdx Will Corp. · 2016
- This deviceK181297 DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp. · 2018
- Descendant · cites it directly · 0 of its ownK201382 X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark…De Gotzen S.R.L. · 2020
Show all 9 generations
- Root · 9 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 8 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 7 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 6 generations backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- 5 generations backK111152 Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011 · Recalled
- 4 generations backK122981 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- 3 generations backK131695 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- 2 generations backK142247 Rayscan a-Expert 3DRay Co., Ltd. · 2015
- 1 generation backK160140 DENTRIa seriesHdx Will Corp. · 2016
- This deviceK181297 DENTIOIII series (DENTIOIII, DENTIOIII-S)Hdx Will Corp. · 2018
Most influential descendants
Showing 1 of 1 · See all- K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)De Gotzen S.R.L. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −8 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −7 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −6 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| −5 | K111152 | Rotograph Evo 3D | Villa Sistemi Medicali S.P.A. | 2011 | 1 |
| −4 | K122981 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| −3 | K131695 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| −2 | K142247 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2015 | — |
| −1 | K160140 | DENTRIa series | Hdx Will Corp. | 2016 | — |
| 0 (this device) | K181297 | DENTIOIII series (DENTIOIII, DENTIOIII-S) | Hdx Will Corp. | 2018 | — |
| +1 | K201382 | X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy… | De Gotzen S.R.L. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 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? (3)
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 |
|---|---|---|---|
| * | K142058 | Rayscan a-ExpertSummary page 5…redicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow; Predicate device #1 - 510(k) Number: K142058 - Applicant: RAY Co., Ltd. - Regulation Name: Extraoral source x-ray system - Product Code:… | 2015 |
| * | K992385 | Orthopantomograph OP100DSummary page 5…Product Code: MUH - Device Class: Class II - Device Name: RAYSCAN α–Expert Predicate device #2 - 510(k) Number: K992385 - Applicant: INSTRUMENTARIUM CORP. - Regulation Name: Extraoral source x-ray system - Product Code:… | 1999 |
| * | K160140 | DENTRIa seriesSummary page 5…ode: MUH - Device Class: Class II - Device Name: Orthopantomograph® OP100 D Predicate device #3 - 510(k) Number: K160140 - Applicant: HDX WILL CORP. - Regulation Name: Computed tomography x-ray system - Product Code:… | 2016 |
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 |
|---|---|---|---|
| K201382 | X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) | 2020 | 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?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 28 ancestors have a recall of any class.
- Of its descendants, K201382 (De Gotzen S.R.L., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K142058.
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. 2018, this device’s year, is highlighted.
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?
The DENTIOIII series is intended for dental radiographic examination of the teeth and temporomandibular joints, specifically for panoramic and cephalometric examinations. It is to be used only by dental practitioners and/or radiologists
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181297 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181297: DENTIOIII series (DENTIOIII, DENTIOIII-S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181297
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