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FDA 510(k)

Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)

K-Number: K254145 · 2026-06-11

ApplicantSmart Denture Conversions, LLC
Decision Date2026-06-11
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) is the device name listed in this FDA 510(k) record. The listed applicant is Smart Denture Conversions, LLC. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K254145. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)?

Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Smart Denture Conversions, LLC. The 510(k) number is K254145.

When did Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) receive FDA 510(k) clearance?

Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) received FDA 510(k) clearance on 2026-06-11, under 510(k) number K254145.

Who is the listed applicant for Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)?

The FDA 510(k) record lists Smart Denture Conversions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)?

The FDA product code for Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) is NHA.

Other records listing Smart Denture Conversions, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242064Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)

Related Devices (Code: NHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K260564DESS Dental Smart SolutionsTerrats Medical SLK252904SIC Abutments including CAD/CAM SolutionsSic Invent AG

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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