Cleared Traditional

Customized Abutment

K242245 · Arum Dentistry Co., Ltd. · Dental

Nov 2024

Decision

117d

Days

Class 2

Risk

About This 510(k) Submission

K242245 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 November 25, 2024, 117 days after receiving the submission on July 31, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K242245 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 31, 2024
Decision Date	November 25, 2024
Days to Decision	117 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.