Cleared Traditional

C&B NFH Hybrid

K232559 · Arum Dentistry Co., Ltd. · Dental
Sep 2024
Decision
385d
Days
Class 2
Risk

About This 510(k) Submission

K232559 is an FDA 510(k) clearance for the C&B NFH Hybrid, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Arum Dentistry Co., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on September 11, 2024, 385 days after receiving the submission on August 23, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K232559 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2023
Decision Date September 11, 2024
Days to Decision 385 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690