# K260082: TRIOS Dx (R1)

- Pathway: 510(k) (Traditional)
- Applicant: 3Shape TRIOS A/S
- Decided: Apr 10, 2026 after 88 days
- Product code: SHQ (Dental Image Analyzer, In-Office)
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN230035 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230035: DentalMonitoring, Dental Monitoring Sas (2024) Summary page 5.

## Indications for use
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

Source page: https://510kreport.com/device/K260082
Methodology: https://510kreport.com/methodology