510(k) K253131
K253131 is an FDA 510(k) premarket notification submitted by Guangzhou Rebornendo Medical Instrument Co., Ltd. for the device "Curing Light (M-Cure 6)". The FDA issued a decision of Substantially Equivalent on June 18, 2026. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 2026
- Date Received
- September 25, 2025
- 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