Cleared Traditional

s-Clean SQ-SL Implant System Regular

K192688 · Dentis Co., Ltd. · Dental
Feb 2020
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K192688 is an FDA 510(k) clearance for the s-Clean SQ-SL Implant System Regular, 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 February 4, 2020, 131 days after receiving the submission on September 26, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K192688 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2019
Decision Date February 04, 2020
Days to Decision 131 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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