510(k) · Cleared
ClearedTRIOS Dx (R1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3Shape TRIOS A/S · SHQ Dental Image Analyzer, In-Office
Cleared on Apr 10, 2026 as substantially equivalent to DEN230035 (Dental Monitoring Sas, 2024) after an 88-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Apr 10, 2026
- Review
- 88 days
- Product code
- SHQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN230035 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backDEN230035 DentalMonitoringDental Monitoring Sas · 2024
- This deviceK260082 TRIOS Dx (R1)3Shape TRIOS A/S · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN230035 | DentalMonitoring | Dental Monitoring Sas | 2024 | — |
| 0 (this device) | K260082 | TRIOS Dx (R1) | 3Shape TRIOS A/S | 2026 | — |
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 SHQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | DEN230035 | DentalMonitoringSummary page 5…r 8721770 Product Code(s) SHQ | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code DEN230035 Dental Monitoring SBC Device Description Summary 21 CFR 807.92(a)(4) Device description summary TRIOS Dx is a software-only med… | 2024 |
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?
- Its one ancestor has no recall.
How does its category compare?
All SHQ devicesSHQ Dental Image Analyzer, In-Office: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SHQ
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SHQ
Too few SHQ 510(k)s in any year since 2007 to give a median.
Recalls per year · SHQ
No recall names SHQ since 2007.
Adverse event reports per year · SHQ
No MAUDE report names SHQ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
TRIOS Dx is intended as an aid in the diagnosis of oral health conditions and the assessment of changes in teeth and gingiva.
TRIOS Dx is intended to aid in the diagnosis and assessment of:
* caries
* tooth wear
* gingival recession
* plaque
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/K260082 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260082: TRIOS Dx (R1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260082
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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