Cleared Traditional

NB 1 SA Implant System

K213506 · Arum Dentistry Co., Ltd. · Dental
Apr 2022
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K213506 is an FDA 510(k) clearance for the NB 1 SA 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 April 6, 2022, 156 days after receiving the submission on November 1, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K213506 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 2021
Decision Date April 06, 2022
Days to Decision 156 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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