510(k) · Cleared
ClearedDTX Studio Clinic 3.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare AB · MYN Analyzer, Medical Image
Cleared on Mar 28, 2023 as substantially equivalent to K213795 (Videahealth, Inc., 2022) and 1 other predicate after a 270-day review. Its family tree reaches back 2 generations to 1998. 5 later devices descend from it.
- Decided
- Mar 28, 2023
- Review
- 270 days
- Class
- Class II
- Product code
- MYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to P980025 (1998). 3 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backP980025 Logicon Caries DetectorCarestream Dental, LLC · 1998 · Recalled
- 1 generation backK210365 Second OpinionPearl, Inc. · 2022
- This deviceK221921 DTX Studio Clinic 3.0Nobel Biocare AB · 2023
- Descendant · cites it directly · 2 of its ownK231678 Overjet Periapical Radiolucency AssistOverjet, Inc. · 2023
- Descendant · cites it directly · 1 of its ownK231898 DTX Studio Clinic (4.0)Nobel Biocare AB · 2023
- Descendant · 2 generations on · 0 of its ownK252934 DiagnocatDgnct, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK252086 DTX Studio AssistNobel Biocare C/O Medicim NV · 2025
- Descendant · 2 generations on · 0 of its ownK242600 Second Opinion Periapical Radiolucency ContoursPearl, Inc. · 2025
Most influential descendants
Showing 5 of 5 · See all- K231678Overjet Periapical Radiolucency AssistOverjet, Inc. · 2023 · cites it directly2descendants
- K231898DTX Studio Clinic (4.0)Nobel Biocare AB · 2023 · cites it directly1descendant
- K252934DiagnocatDgnct, LLC · 2026 · 2 generations on0descendants
- K252086DTX Studio AssistNobel Biocare C/O Medicim NV · 2025 · 2 generations on0descendants
- K242600Second Opinion Periapical Radiolucency ContoursPearl, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P980025 | Logicon Caries Detector | Carestream Dental, LLC | 1998 | 1 |
| −1 | K210365 | Second Opinion | Pearl, Inc. | 2022 | — |
| 0 (this device) | K221921 | DTX Studio Clinic 3.0 | Nobel Biocare AB | 2023 | — |
| +1 | K231678 | Overjet Periapical Radiolucency Assist | Overjet, Inc. | 2023 | — |
| +1 | K231898 | DTX Studio Clinic (4.0) | Nobel Biocare AB | 2023 | — |
| +2 | K252934 | Diagnocat | Dgnct, LLC | 2026 | — |
| +2 | K252086 | DTX Studio Assist | Nobel Biocare C/O Medicim NV | 2025 | — |
| +2 | K242600 | Second Opinion Periapical Radiolucency Contours | Pearl, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 29.9 · 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 |
|---|---|---|---|
| * | K213795 | Videa Caries AssistSummary page 4…lass: II III. Predicate Device Substantial equivalence is claimed to the following devices: Primary Predicate: Predicate Device: Videa Caries Assist Predicate 510(k): K213795 Company: Videa Health, Inc Common or Usual Name: Medical Image Analyzer Regulation Number: 21 CFR 892.2070 Classification Name: M… | 2022 |
| * | K210365 | Second OpinionSummary page 5…K221921 Product Code: MYN Device Class: II Secondary Predicate: Predicate Device: Second Opinion Predicate 510(k): K210365 Company: Pearl Inc. Common or Usual Name: Medical Image Analyzer Regulation Number: 21 CFR 892.2070 Classification Name: Medical… | 2022 |
What descends from it? (5)
2 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?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 23.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K231678 (Overjet, Inc., 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K213795.
How does its category compare?
All MYN devicesMYN Analyzer, Medical Image: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Clinic is a computer assisted detection (CADe) device that analyses intraoral radiographs to identify and localize dental findings, which include caries, calculus, periapical radiolucency, root canal filling deficiency, discrepancy at margin of an existing restoration and bone loss.
The DTX Studio Clinic CADe functionality is indicated for use by dentists for the concurrent review of bitewing and periapical radiographs of permanent teeth in patients 15 years of age or older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221921: DTX Studio Clinic 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221921
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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