510(k) K223507

CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) by Good Doctors Co., Ltd. — Product Code EBZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2023
Date Received
November 22, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activator, Ultraviolet, For Polymerization
Device Class
Class II
Regulation Number
872.6070
Review Panel
DE
Submission Type