Cleared Traditional

ET SMARTFIT ABUTMENT

K123627 · Hiossen, Inc. · Dental

Jun 2013

Decision

217d

Days

Class 2

Risk

About This 510(k) Submission

K123627 is an FDA 510(k) clearance for the ET SMARTFIT 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 June 28, 2013, 217 days after receiving the submission on November 23, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K123627 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 23, 2012
Decision Date	June 28, 2013
Days to Decision	217 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.