meddevicedb.com FDA Device Reference

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

K223507 Class II Traditional
Decision Date
2023-08-04
Sponsor / Applicant
Good Doctors Co., Ltd.

Technical Specification

510(k) Submission ID K223507
Product Code EBZ
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.6070
Decision Date 2023-08-04
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) received FDA 510(k) clearance under submission number K223507, sponsored by Good Doctors Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2023-08-04.

Classification & Regulation

This clearance is catalogued under FDA product code EBZ and 21 CFR 872.6070, within the Dental review panel as a Class II device.