Curing Light (M-Cure 6)— 510(k) K253131
Substantially EquivalentGuangzhou Rebornendo Medical Instrument Co., Ltd.
FDA 510(k) clearance K253131 for Curing Light (M-Cure 6), Substantially Equivalent on 2026-06-18. Applicant: Guangzhou Rebornendo Medical Instrument Co., Ltd.. Device class: 2.
Summary
Guangzhou Rebornendo Medical Instrument's Curing Light (M-Cure 6) is filed under EBZ, ultraviolet activators for polymerization. The record doesn't describe the light beyond the model name and the code name.
Class II, 21 CFR 872.6070. Dental is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Rebornendo filed from Guangzhou, China. Review took 266 calendar days (September 25, 2025 to June 18, 2026).
Clearance details
- Applicant
- Guangzhou Rebornendo Medical Instrument Co., Ltd.
- Product code
- Product code EBZ
- Device class
- Class 2
- Regulation
- 21 CFR 872.6070
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guangzhou, CN
Recent devices under product code EBZ
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