Cleared Traditional

K123627 - ET SMARTFIT ABUTMENT

K123627 is the FDA 510(k) clearance for ET SMARTFIT ABUTMENT by Hiossen, Inc.. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K123627 · Hiossen, Inc. · Dental device
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Jun 2013
Decision
217d
Days
Class 2
Risk

K123627 is an FDA 510(k) clearance for the ET SMARTFIT ABUTMENT. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Hiossen, Inc. (Fariless Hills, US). The FDA issued a Cleared decision on June 28, 2013 after a review of 217 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Hiossen, Inc. devices

Submission Details

510(k) Number K123627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 127d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NHA Abutment, Implant, Dental, Endosseous

All 464
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