Cleared Traditional

K240603 - Ti-Base & Master Fix
(FDA 510(k) Clearance)

K240603 · Arum Dentistry Co., Ltd. · Dental

Jun 2024

Decision

93d

Days

Class 2

Risk

K240603 is an FDA 510(k) clearance for the Ti-Base & Master Fix. This device is classified as 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 June 5, 2024, 93 days after receiving the submission on March 4, 2024.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3630. To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation..

Submission Details

510(k) Number	K240603 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 04, 2024
Decision Date	June 05, 2024
Days to Decision	93 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.