Cleared Traditional

ET Hybrid Abutment

K170421 · Hiossen, Inc. · Dental

Jan 2018

Decision

332d

Days

Class 2

Risk

About This 510(k) Submission

K170421 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 11, 2018, 332 days after receiving the submission on February 13, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K170421 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 13, 2017
Decision Date	January 11, 2018
Days to Decision	332 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.