Cleared Traditional

s-Clean SQ-SL Implant System Mini

K200099 · Dentis Co., Ltd. · Dental
Apr 2020
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K200099 is an FDA 510(k) clearance for the s-Clean SQ-SL Implant System 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 April 13, 2020, 88 days after receiving the submission on January 16, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K200099 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 2020
Decision Date April 13, 2020
Days to Decision 88 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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