Cleared Traditional

TruAbutment DS, TruBase (K203649) - FDA 510(k) Clearance

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

K203649 · Truabutment, Inc. · Dental device
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Sep 2021
Decision
275d
Days
Class 2
Risk

K203649 is an FDA 510(k) clearance for the TruAbutment DS, TruBase. 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. (Irvine, US). The FDA issued a Cleared decision on September 15, 2021 after a review of 275 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 K203649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2020
Decision Date September 15, 2021
Days to Decision 275 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
148d slower than avg
Panel avg: 127d · This submission: 275d
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 318
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K203649.
Multi-unit Abutment, Multi-unit Angled Abutment
K203808 · Megagen Implant Co., Ltd. · Oct 2021
Straumann CARES P-Series CAD/CAM System
K203750 · Institut Straumann AG · Oct 2021
Dynamic TiBase
K212108 · Talladium Espa?a, SL · Sep 2021
s-Clean Pre-Milled Abutment Mini
K210410 · Dentis Co., Ltd. · Sep 2021
Premilled Titanium Block System
K203344 · Innobiosurg Co., Ltd. · Aug 2021
s-Clean Pre-Milled Abutment
K210362 · Dentis Co., Ltd. · Aug 2021