LED Curing Light (C01-X, C02-X)— 510(k) K250009

Substantially Equivalent

Premium Plus (Dongguan) Limited

FDA 510(k) clearance K250009 for LED Curing Light (C01-X, C02-X), Substantially Equivalent on 2025-04-10. Applicant: Premium Plus (Dongguan) Limited.

Clearance details

Applicant: Premium Plus (Dongguan) Limited
Product code: Code EBZ
Advisory panel: Dental
Date received: 2025-01-02
Decision date: 2025-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan, CN

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