Cleared Traditional

s-Clean Pre-Milled Abutment Mini

K210410 · Dentis Co., Ltd. · Dental

Sep 2021

Decision

211d

Days

Class 2

Risk

About This 510(k) Submission

K210410 is an FDA 510(k) clearance for the s-Clean Pre-Milled 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 September 10, 2021, 211 days after receiving the submission on February 11, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K210410 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 2021
Decision Date	September 10, 2021
Days to Decision	211 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.