Cleared Traditional

ET US SS Prosthetic system

K160670 · Osstem Implant Co., Ltd. · Dental

Apr 2017

Decision

411d

Days

Class 2

Risk

About This 510(k) Submission

K160670 is an FDA 510(k) clearance for the ET US SS Prosthetic 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 April 25, 2017, 411 days after receiving the submission on March 10, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K160670 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 10, 2016
Decision Date	April 25, 2017
Days to Decision	411 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.