Cleared Traditional

Dentis s-Clean s-Line

K210134 · Dentis Co., Ltd. · Dental
Apr 2021
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K210134 is an FDA 510(k) clearance for the Dentis s-Clean s-Line, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Dentis Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on April 19, 2021, 90 days after receiving the submission on January 19, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K210134 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2021
Decision Date April 19, 2021
Days to Decision 90 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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