Cleared Traditional

Angled Abutment

K232560 · Arum Dentistry Co., Ltd. · Dental

Dec 2023

Decision

118d

Days

Class 2

Risk

About This 510(k) Submission

K232560 is an FDA 510(k) clearance for the Angled 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 December 19, 2023, 118 days after receiving the submission on August 23, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K232560 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 23, 2023
Decision Date	December 19, 2023
Days to Decision	118 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.