Cleared Traditional

Dentis s-Clean SQ-SL Fixture

K240511 · Dentis Co., Ltd. · Dental
May 2024
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K240511 is an FDA 510(k) clearance for the Dentis s-Clean SQ-SL Fixture, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Dentis Co., Ltd. (Dalseo-Gu, KR). The FDA issued a Cleared decision on May 20, 2024, 88 days after receiving the submission on February 22, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K240511 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2024
Decision Date May 20, 2024
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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