Cleared Traditional

Dentis s-Clean SQ-SL Narrow Implant System

K230246 · Dentis Co., Ltd. · Dental

May 2023

Decision

115d

Days

Class 2

Risk

About This 510(k) Submission

K230246 is an FDA 510(k) clearance for the Dentis s-Clean SQ-SL Narrow Implant System, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Dentis Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on May 25, 2023, 115 days after receiving the submission on January 30, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K230246 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 2023
Decision Date	May 25, 2023
Days to Decision	115 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NHA — Abutment, Implant, Dental, Endosseous
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3630
Definition	To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.