Cleared Traditional

CL-DP40 (Dr?s Light PRIME), CL-DP40 (Dr?s Light CHOICE)

K223507 · Good Doctors Co., Ltd. · Dental

Aug 2023

Decision

255d

Days

Class 2

Risk

About This 510(k) Submission

K223507 is an FDA 510(k) clearance for the CL-DP40 (Dr?s Light PRIME), CL-DP40 (Dr?s Light CHOICE), a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ), submitted by Good Doctors Co., Ltd. (Incheon, KR). The FDA issued a Cleared decision on August 4, 2023, 255 days after receiving the submission on November 22, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number	K223507 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 22, 2022
Decision Date	August 04, 2023
Days to Decision	255 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF