Cleared Traditional

Customized Abutment

K234112 · Arum Dentistry Co., Ltd. · Dental

May 2024

Decision

134d

Days

Class 2

Risk

About This 510(k) Submission

K234112 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 May 9, 2024, 134 days after receiving the submission on December 27, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K234112 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 27, 2023
Decision Date	May 09, 2024
Days to Decision	134 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.