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

Name: FDA 510(k) clearance K250009
Creator: U.S. Food and Drug Administration
Published: 2025-04-10

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. Device class: 2.

Clearance details

Applicant: Premium Plus (Dongguan) Limited
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 2025-01-02
Decision date: 2025-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan, CN

Download summary PDF View on FDA.gov ↗

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K243921 — LED Curing Lights (DB686 HALO)2025-04-11
K241238 — LOOP LED Curing Light System (CLK01)2024-08-01

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Data sourced from openFDA. This site is unofficial and independent of the FDA.