Cleared Traditional

Customized Abutment

K223634 · Arum Dentistry Co., Ltd. · Dental

Apr 2023

Decision

144d

Days

Class 2

Risk

About This 510(k) Submission

K223634 is an FDA 510(k) clearance for the Customized Abutment, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Arum Dentistry Co., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on April 28, 2023, 144 days after receiving the submission on December 5, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K223634 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 05, 2022
Decision Date	April 28, 2023
Days to Decision	144 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.