Cleared Traditional

Bluemoon

K242386 · Genoss Co., Ltd. · Dental
May 2025
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K242386 is an FDA 510(k) clearance for the Bluemoon, a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ), submitted by Genoss Co., Ltd. (Suwon-Si, CN). The FDA issued a Cleared decision on May 5, 2025, 266 days after receiving the submission on August 12, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number K242386 FDA.gov
FDA Decision Cleared SESE
Date Received August 12, 2024
Decision Date May 05, 2025
Days to Decision 266 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBZ — Activator, Ultraviolet, For Polymerization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6070

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