Cleared Traditional

OSSTEM Implant System - Abutment

K161689 · Osstem Implant Co., Ltd. · Dental

May 2017

Decision

336d

Days

Class 2

Risk

About This 510(k) Submission

K161689 is an FDA 510(k) clearance for the OSSTEM Implant System - Abutment, 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 May 22, 2017, 336 days after receiving the submission on June 20, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K161689 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2016
Decision Date	May 22, 2017
Days to Decision	336 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.