510(k) K223507
K223507 is an FDA 510(k) premarket notification submitted by Good Doctors Co., Ltd. for the device "CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE)". The FDA issued a decision of Substantially Equivalent on August 4, 2023. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070. Good Doctors Co., Ltd. has at least 6 other 510(k) clearances on record.
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