Cleared Traditional

N1

K232012 · Osstem Implant Co., Ltd. · Radiology
Nov 2023
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K232012 is an FDA 510(k) clearance for the N1, a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Osstem Implant Co., Ltd. (Siheung-Si, KR). The FDA issued a Cleared decision on November 28, 2023, 145 days after receiving the submission on July 6, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K232012 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2023
Decision Date November 28, 2023
Days to Decision 145 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code EHD — Unit, X-ray, Extraoral With Timer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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