Cleared Traditional

K170259 - TruAbutment DS

K170259 is an FDA 510(k) clearance for TruAbutment DS, manufactured by Truabutment. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K170259 · Truabutment · Dental device
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May 2017
Decision
118d
Days
Class 2
Risk

K170259 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 (Anaheim, US). The FDA issued a Cleared decision on May 25, 2017 after a review of 118 days - within the typical 510(k) review window.

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 devices

FDA 510(k) Submission Details - K170259

510(k) Number K170259 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2017
Decision Date May 25, 2017
Days to Decision 118 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
9d faster than avg
Panel avg: 127d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHA Device Classification - Class 2, Special Controls

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 542
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K170259.
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K170354 · Institut Straumann AG · Jun 2017
Straumann Variobase Abutments
K170356 · Institut Straumann AG · Jun 2017
Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System
K170044 · Prismatik Dentalcraft, Inc. · Jun 2017
OSSTEM Implant System - Abutment
K161689 · Osstem Implant Co., Ltd. · May 2017
ET US SS Prosthetic system
K160670 · Osstem Implant Co., Ltd. · Apr 2017
Multibase Abutments EV and ATLANTIS Suprastructures
K163350 · Dentsply Sirona · Mar 2017