Cleared Traditional

LED Curing Light (C01-X, C02-X)

K250009 · Premium Plus (Dongguan) Limited · Dental

Apr 2025

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K250009 is an FDA 510(k) clearance for the LED Curing Light (C01-X, C02-X), a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ), submitted by Premium Plus (Dongguan) Limited (Dongguan, CN). The FDA issued a Cleared decision on April 10, 2025, 98 days after receiving the submission on January 2, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number	K250009 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 02, 2025
Decision Date	April 10, 2025
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF