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FDA 510(k)

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

N.º K: K254145 · 2026-06-11

SolicitanteSmart Denture Conversions, LLC
Fecha de decisión2026-06-11
Código de productoNHA
Comité asesorDE
DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Smart Denture Conversions, LLC como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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

Dispositivos relacionados (Código: NHA)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLCK253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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