Cleared Traditional

s-Clean Pre-Milled Abutment

K210362 · Dentis Co., Ltd. · Dental

Aug 2021

Decision

192d

Days

Class 2

Risk

About This 510(k) Submission

K210362 is an FDA 510(k) clearance for the s-Clean Pre-Milled Abutment, 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 August 19, 2021, 192 days after receiving the submission on February 8, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K210362 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 08, 2021
Decision Date	August 19, 2021
Days to Decision	192 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.