Cleared Traditional

TS Abutment System

K233194 · Osstem Implant Co., Ltd. · Dental

Feb 2024

Decision

145d

Days

Class 2

Risk

About This 510(k) Submission

K233194 is an FDA 510(k) clearance for the TS Abutment System, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Osstem Implant Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on February 20, 2024, 145 days after receiving the submission on September 28, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K233194 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2023
Decision Date	February 20, 2024
Days to Decision	145 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.