Cleared Traditional

Dentis i-Clean System

K230307 · Dentis Co., Ltd. · Dental

Jul 2023

Decision

158d

Days

Class 2

Risk

About This 510(k) Submission

K230307 is an FDA 510(k) clearance for the Dentis i-Clean 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 July 11, 2023, 158 days after receiving the submission on February 3, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K230307 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 03, 2023
Decision Date	July 11, 2023
Days to Decision	158 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.