Cleared Traditional

s-Clean Link Abutment Narrow

K230523 · Dentis Co., Ltd. · Dental

May 2023

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K230523 is an FDA 510(k) clearance for the s-Clean Link Abutment Narrow, 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 24, 2023, 86 days after receiving the submission on February 27, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K230523 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 2023
Decision Date	May 24, 2023
Days to Decision	86 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.