510(k) · Cleared
ClearedDTX Studio Assist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare C/O Medicim NV · MYN Analyzer, Medical Image
Cleared on Nov 17, 2025 as substantially equivalent to K231898 (Nobel Biocare AB, 2023) and 1 other predicate after a 138-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Nov 17, 2025
- Review
- 138 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K954678 (1996). 44 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 12 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 8 generations between
- 3 generations backK203156 DTX Studio ClinicNobel Biocare AB · 2020
- 2 generations backK213562 DTX Studio Clinic 3.0Nobel Biocare AB · 2022
- 1 generation backK231898 DTX Studio Clinic (4.0)Nobel Biocare AB · 2023
- This deviceK252086 DTX Studio AssistNobel Biocare C/O Medicim NV · 2025
Show all 12 generations
- Root · 12 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 11 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 10 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 9 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 8 generations backK053155 VimplantCybermed, Inc. · 2005
- 7 generations backK070803 InvivodentalAnatomage, Inc. · 2007
- 6 generations backK123519 Invivo DentalAnatomage, Inc. · 2013
- 5 generations backK140713 Planmeca RomexisPlanmeca Oy · 2014
- 4 generations backK162799 CliniviewPalodex Group OY · 2017
- 3 generations backK203156 DTX Studio ClinicNobel Biocare AB · 2020
- 2 generations backK213562 DTX Studio Clinic 3.0Nobel Biocare AB · 2022
- 1 generation backK231898 DTX Studio Clinic (4.0)Nobel Biocare AB · 2023
- This deviceK252086 DTX Studio AssistNobel Biocare C/O Medicim NV · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −11 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −10 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −9 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −8 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| −7 | K070803 | Invivodental | Anatomage, Inc. | 2007 | — |
| −6 | K123519 | Invivo Dental | Anatomage, Inc. | 2013 | — |
| −5 | K140713 | Planmeca Romexis | Planmeca Oy | 2014 | — |
| −4 | K162799 | Cliniview | Palodex Group OY | 2017 | — |
| −3 | K203156 | DTX Studio Clinic | Nobel Biocare AB | 2020 | — |
| −2 | K213562 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2022 | — |
| −1 | K231898 | DTX Studio Clinic (4.0) | Nobel Biocare AB | 2023 | — |
| 0 (this device) | K252086 | DTX Studio Assist | Nobel Biocare C/O Medicim NV | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 MYN? 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 MYN device
- #1 K210365 Second Opinionscore 30.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K231898 | DTX Studio Clinic (4.0)Summary page 5…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code I K231898 DTX Studio Clinic 4.0 MYN 1 K242437… | 2023 |
| * | K242437 | Smile Dx®Summary page 5…Product Code I K231898 DTX Studio Clinic 4.0 MYN 1 K242437 Smile Dx MYN Device Descri… | 2025 |
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?
- The line of descent spans 29 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 44 ancestors have a recall of any class.
How does its category compare?
All MYN devicesMYN Analyzer, Medical Image: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MYN
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MYN
210in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MYN
No recall names MYN since 2007.
Adverse event reports per year · MYN
2in 2025
MAUDE reports naming product code MYN, 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 | 5 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 6 | — | 0 | 0 |
| 2013 | 4 | — | 0 | 0 |
| 2014 | 3 | — | 0 | 0 |
| 2015 | 3 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 3 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 5 | 273 | 0 | 0 |
| 2023 | 10 | 229 | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 14 | 210 | 0 | 2 |
| 2026 | 7 | 128 | 0 | — |
What is it indicated for?
DTX Studio Assist is a Software Development Kit (SDK) designed to integrate with medical device software that displays two-dimensional dental radiographs. It contains a selection of algorithms that processes input data (two-dimensional radiographs) from the hosting application and returns a corresponding output to it. DTX Studio Assist is intended to support the measurement of alveolar bone levels associated with each tooth. It is also intended to aid in…
Read the full statement (166 words)
DTX Studio Assist is a Software Development Kit (SDK) designed to integrate with medical device software that displays two-dimensional dental radiographs. It contains a selection of algorithms that processes input data (two-dimensional radiographs) from the hosting application and returns a corresponding output to it.
DTX Studio Assist is intended to support the measurement of alveolar bone levels associated with each tooth. It is also intended to aid in the detection and segmentation of non-pathological structures (i.e., restorations and dental anatomy).
DTX Studio Assist contains a computer-assisted detection (CADe) function that analyzes bitewing and periapical radiographs of permanent teeth in patients aged 15 and older to identify and localize dental findings, including caries, calculus, periapical radiolucency, root canal filling deficiency, discrepancy at the margin of an existing restoration, and bone loss.
DTX Studio Assist is not intended as a replacement for a complete dentist's review nor their clinical judgment which takes into account other relevant information from the image, patient history, and actual in vivo clinical assessment
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/K252086 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252086: DTX Studio Assist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252086
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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