Cleared Traditional

Estar-Z

K210097 · Osstem Implant Co., Ltd. · Dental
Jul 2021
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K210097 is an FDA 510(k) clearance for the Estar-Z, a Powder, Porcelain (Class II — Special Controls, product code EIH), submitted by Osstem Implant Co., Ltd. (Siheung-Si, KR). The FDA issued a Cleared decision on July 2, 2021, 169 days after receiving the submission on January 14, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number K210097 FDA.gov
FDA Decision Cleared SESE
Date Received January 14, 2021
Decision Date July 02, 2021
Days to Decision 169 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EIH — Powder, Porcelain
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6660

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