Cleared Traditional

Dentis s-Clean Abutment Mini

K220440 · Dentis Co., Ltd. · Dental

Jun 2022

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K220440 is an FDA 510(k) clearance for the Dentis s-Clean Abutment Mini, 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 June 16, 2022, 120 days after receiving the submission on February 16, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K220440 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 16, 2022
Decision Date	June 16, 2022
Days to Decision	120 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.