Dental · 510(k) · 2026
TRIOS Dx (R1)
3Shape TRIOS A/S. Cleared by FDA on 10 April 2026 under submission K260082, product code SHQ (dental image analyzer, in-office). What FDA's record says, in FDA's words.
Device record · K260082
- Device. TRIOS Dx (R1)DEVICE
- Company. 3Shape TRIOS A/S (DK)COMPANY
- Decision. 10 April 2026, 510(k), substantially equivalent (traditional review); received 12 January 2026DECISION
- Panel. DentalPANEL
- Product code. SHQ, Dental Image Analyzer, In-OfficeCODE
- Regulation. 21 CFR 872.1770, Class IIREG
- Source. FDA database entry · decision document (7 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
if it is known. This K260082Please type in the marketing application/submission number, textbox will be left blank for original applications/submissions. Please provide the device trade name(s). ? TRIOS Dx (R1) Please provide your Indications for Use below. 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 I Please select the types of uses (select one or both, as ZPrescription Use (21 CFR 801 Subpart D) S]Over-The-Counter Use (21 CFR 801 Subpart C)applicable). K260082
The product code's definition, from FDA's classification record. 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsa diagnostic claim
- Mentionsprescription use
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SHQ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SHQ, in Dental, or cleared in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.