Cleared Traditional

s-Clean ScanHealing Abutment

K241063 · Dentis Co., Ltd. · Dental

Jul 2024

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K241063 is an FDA 510(k) clearance for the s-Clean ScanHealing Abutment, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Dentis Co., Ltd. (Dalseo-Gu, KR). The FDA issued a Cleared decision on July 25, 2024, 98 days after receiving the submission on April 18, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K241063 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 18, 2024
Decision Date	July 25, 2024
Days to Decision	98 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.