Devices · 3Shape TRIOS A/S

TRIOS Dx (R1)

3Shape TRIOS A/S is listed for TRIOS Dx (R1) (K260082). The FDA list gives April 10, 2026 as the date of the final decision. The lead panel is Dental, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code SHQ as “Dental Image Analyzer, In-Office”: A dental image analyzer for in-office use is a prescription device that uses software intended to collect and analyze patient-specific, optical camera-based, intraoral images to be used by dental health care professionals as an aid to diagnosis of oral health conditions. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260082

Official FDA database record

Date of final decision

April 10, 2026

Company on the FDA list

3Shape TRIOS A/S

Lead panel

Dental

Primary product code

SHQ

openFDA device name for the code

Dental Image Analyzer, In-Office

Device class

2

Regulation number

872.1770

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary