Cleared Abbreviated

K254145 - Omni-Directional Multi-Unit Abutment Sy...

K254145 is an FDA 510(k) clearance for Omni-Directional Multi-Unit Abutment Sy..., manufactured by Smart Denture Conversions, LLC. The device is a Class 2 Dental device with product code NHA cleared through the Abbreviated 510(k) pathway after a 171-day FDA review.

K254145 · Smart Denture Conversions, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
171d
Days
Class 2
Risk

K254145 is an FDA 510(k) clearance for the Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™). 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 Smart Denture Conversions, LLC (Apex, US). The FDA issued a Cleared decision on June 11, 2026 after a review of 171 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Smart Denture Conversions, LLC devices

FDA 510(k) Submission Details - K254145

510(k) Number K254145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2025
Decision Date June 11, 2026
Days to Decision 171 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 127d · This submission: 171d
Pathway characteristics
Standards-based clearance path.

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 540
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