Cleared Traditional

TruBase S (K171532) - FDA 510(k) Clearance

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

K171532 · Truabutment, Inc. · Dental device
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Sep 2018
Decision
474d
Days
Class 2
Risk

K171532 is an FDA 510(k) clearance for the TruBase S. 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 September 11, 2018 after a review of 474 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Truabutment, Inc. devices

Submission Details

510(k) Number K171532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2017
Decision Date September 11, 2018
Days to Decision 474 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
347d slower than avg
Panel avg: 127d · This submission: 474d
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 K171532.
Sirona Dental CAD/CAM System
K181520 · Dentsply Sirona · Oct 2018
Straumann SC Variobase Abutments
K173945 · Institut Straumann AG · Oct 2018
BioHorizons CAD/CAM Bars
K180998 · BioHorizons Implant Systems, Inc. · Sep 2018
InterActive SMARTBase Abutments
K181359 · Implant Direct Sybron Manufacturing, LLC · Aug 2018
ATLANTIS Conus Structure
K181189 · Dentsply Sirona · Jul 2018
Straumann Variobase for Bridge/Bar Cylindrical
K173968 · Institut Straumann AG · Jul 2018