Cleared Traditional

Monet Curing Laser

K201904 · CAO Group, Inc. · Dental
Nov 2020
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K201904 is an FDA 510(k) clearance for the Monet Curing Laser, a Laser Activator For Polymerization (Class II — Special Controls, product code QNF), submitted by CAO Group, Inc. (West Jordan, US). The FDA issued a Cleared decision on November 24, 2020, 138 days after receiving the submission on July 9, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K201904 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 2020
Decision Date November 24, 2020
Days to Decision 138 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code QNF — Laser Activator For Polymerization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6070
Definition Intended To Polymerize Dental Restorative Resins