Cleared Traditional

Osstem Implant System

K222778 · Osstem Implant Co., Ltd. · Dental
Sep 2023
Decision
374d
Days
Class 2
Risk

About This 510(k) Submission

K222778 is an FDA 510(k) clearance for the Osstem Implant System, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Osstem Implant Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on September 23, 2023, 374 days after receiving the submission on September 14, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K222778 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 2022
Decision Date September 23, 2023
Days to Decision 374 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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