Cleared Traditional

ET Hybrid Abutment

K162390 · Hiossen, Inc. · Dental

Jan 2017

Decision

157d

Days

Class 2

Risk

About This 510(k) Submission

K162390 is an FDA 510(k) clearance for the ET Hybrid Abutment, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Hiossen, Inc. (Fariless Hills, US). The FDA issued a Cleared decision on January 30, 2017, 157 days after receiving the submission on August 26, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K162390 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 26, 2016
Decision Date	January 30, 2017
Days to Decision	157 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.