Cleared Traditional

TruAbutment DS (K172304) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172304 · Truabutment, Inc. · Dental device
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Jan 2018
Decision
176d
Days
Class 2
Risk

K172304 is an FDA 510(k) clearance for the TruAbutment DS. 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 Truabutment, Inc. (Anaheim, US). The FDA issued a Cleared decision on January 23, 2018 after a review of 176 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 Truabutment, Inc. devices

Submission Details

510(k) Number K172304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2017
Decision Date January 23, 2018
Days to Decision 176 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
49d slower than avg
Panel avg: 127d · This submission: 176d
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 Consultant

Withus Group, Inc.
April Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NHA Abutment, Implant, Dental, Endosseous

All 318
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K172304.
Southern Implants PEEK Abutments
K172160 · Southern Implants (Pty), Ltd. · Feb 2018
PREMIUM Implant Systems SHELTA Implant Systems
K161989 · Sweden & Martina S.P.A. · Feb 2018
Panthera Dental Milled Bars
K173466 · Panthera Dental, Inc. · Jan 2018
Elos Accurate Customized Abutment, Elos Prosthetic Screw
K171799 · Elos Medtech Pinol A/S · Jan 2018
ET Hybrid Abutment
K170421 · Hiossen, Inc. · Jan 2018
Dentium Ti-Base
K171622 · Dentium Co., Ltd. · Jan 2018