Cleared Traditional

Pre-Milled Blank

K193425 · Arum Dentistry Co., Ltd. · Dental

Mar 2020

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K193425 is an FDA 510(k) clearance for the Pre-Milled Blank, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Arum Dentistry Co., Ltd. (Yuseong-Gu, Daejeon, KR). The FDA issued a Cleared decision on March 9, 2020, 90 days after receiving the submission on December 10, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K193425 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 10, 2019
Decision Date	March 09, 2020
Days to Decision	90 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.