Cleared Traditional

Curing Light, Model: MaxCure 9

K223414 · Guilin Refine Medical Instrument Co., Ltd. · Dental

Nov 2023

Decision

370d

Days

Class 2

Risk

About This 510(k) Submission

K223414 is an FDA 510(k) clearance for the Curing Light, Model: MaxCure 9, a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ), submitted by Guilin Refine Medical Instrument Co., Ltd. (Guilin, CN). The FDA issued a Cleared decision on November 15, 2023, 370 days after receiving the submission on November 10, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number	K223414 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 10, 2022
Decision Date	November 15, 2023
Days to Decision	370 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF