L1P-1F (TRIOS 5)— 510(k) K221249

Substantially Equivalent

3Shape TRIOS A/S

FDA 510(k) clearance K221249 for L1P-1F (TRIOS 5), Substantially Equivalent on 2022-09-16. Applicant: 3Shape TRIOS A/S. Device class: 2.

Clearance details

Applicant: 3Shape TRIOS A/S
Product code: Code NBL
Device class: Class 2
Regulation: 21 CFR 872.1745
Advisory panel: Dental
Date received: 2022-05-02
Decision date: 2022-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Copenhagen, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code NBL

K252464 — Surgical Microscope (OMS2360, OMS2380)2026-04-28
K242103 — TRIOS Ready Tip2025-04-04
K221275 — Qraycam PRO2024-09-04
K231722 — SmarTooth2024-05-01
K223470 — C502023-12-14

More clearances from 3Shape TRIOS A/S

K260082 — TRIOS Dx (R1)2026-04-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.