Cleared Traditional

Mimics Enlight CMF

K223427 · Materialise NV · Dental
May 2024
Decision
564d
Days
Class 2
Risk

About This 510(k) Submission

K223427 is an FDA 510(k) clearance for the Mimics Enlight CMF, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on May 31, 2024, 564 days after receiving the submission on November 14, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K223427 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2022
Decision Date May 31, 2024
Days to Decision 564 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050