Cleared Traditional

Dentis s-Clean s-Line Mini

K210080 · Dentis Co., Ltd. · Dental
Jun 2021
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K210080 is an FDA 510(k) clearance for the Dentis s-Clean s-Line Mini, 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 June 4, 2021, 143 days after receiving the submission on January 12, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K210080 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 2021
Decision Date June 04, 2021
Days to Decision 143 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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