Cleared Traditional

C&B 5.0 Hybrid

K210817 · Arum Dentistry Co., Ltd. · Dental
Dec 2021
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K210817 is an FDA 510(k) clearance for the C&B 5.0 Hybrid, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Arum Dentistry Co., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on December 8, 2021, 265 days after receiving the submission on March 18, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K210817 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2021
Decision Date December 08, 2021
Days to Decision 265 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBG — Crown And Bridge, Temporary, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3770

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