Cleared Traditional

NB Implant System

K230725 · Arum Dentistry Co., Ltd. · Dental
Jul 2023
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K230725 is an FDA 510(k) clearance for the NB Implant System, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Arum Dentistry Co., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on July 1, 2023, 107 days after receiving the submission on March 16, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K230725 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 2023
Decision Date July 01, 2023
Days to Decision 107 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

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