Cleared Traditional

Ti Link Abutment

K232170 · Izenimplant Co., Ltd. · Dental

Jan 2024

Decision

175d

Days

Class 2

Risk

About This 510(k) Submission

K232170 is an FDA 510(k) clearance for the Ti Link Abutment, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Izenimplant Co., Ltd. (Pyeongtaek-Si, KR). The FDA issued a Cleared decision on January 12, 2024, 175 days after receiving the submission on July 21, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K232170 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 21, 2023
Decision Date	January 12, 2024
Days to Decision	175 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.