Cleared Traditional

K170421 - ET Hybrid Abutment

K170421 is the FDA 510(k) clearance for ET Hybrid Abutment by Hiossen, Inc.. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K170421 · Hiossen, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
332d
Days
Class 2
Risk

K170421 is an FDA 510(k) clearance for the ET Hybrid 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 January 11, 2018 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K170421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
205d slower than avg
Panel avg: 127d · This submission: 332d
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 463
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K170421.
Panthera Dental Milled Bars
K173466 · Panthera Dental, Inc. · Jan 2018
TruAbutment DS
K172304 · Truabutment, Inc. · Jan 2018
Elos Accurate Customized Abutment, Elos Prosthetic Screw
K171799 · Elos Medtech Pinol A/S · Jan 2018
Dentium Ti-Base
K171622 · Dentium Co., Ltd. · Jan 2018
Straumann CARES Abutments CoCr
K172798 · Institut Straumann AG · Jan 2018
NobelPerfect Abutments
K172854 · Nobel Biocare AB · Dec 2017