Cleared Traditional

s-Clean SQ-SL Implant System Mini

K202773 · Dentis Co., Ltd. · Dental
Mar 2021
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K202773 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 March 18, 2021, 178 days after receiving the submission on September 21, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K202773 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2020
Decision Date March 18, 2021
Days to Decision 178 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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