FDA applicant

3Shape TRIOS A/S

Copenhagen, DK3 decisions2022–20260 recalls

FDA records 3 decisions for 3Shape TRIOS A/S (Copenhagen, DK) from 2022 to 2026: 3 510(k) clearances. Most are in product codes NBL (Light-Induced Fluorescence Caries Detector) and SHQ (Dental Image Analyzer, In-Office). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided 3Shape TRIOS A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — 3Shape TRIOS A/S by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like 3Shape TRIOS A/S’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “3Shape”

FDA records each applicant name separately; these may or may not be the same firm.

3Shape A/S 8 3Shape Medical A/S 3

3Shape TRIOS A/S

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “3Shape”