FDA 510(k)

Esthetic Abutments Nobel Biocare N1

N.º K: K220339 · 2022-09-16

Fecha de decisión2022-09-16

Código de productoNHA

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Esthetic Abutments Nobel Biocare N1 is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare Services AG. It received FDA 510(k) clearance on 2022-09-16 under 510(k) number K220339. 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 Esthetic Abutments Nobel Biocare N1?

Esthetic Abutments Nobel Biocare N1 is a medical device that received FDA 510(k) clearance on 2022-09-16. The listed applicant is Nobel Biocare Services AG. The 510(k) number is K220339.

When did Esthetic Abutments Nobel Biocare N1 receive FDA 510(k) clearance?

Esthetic Abutments Nobel Biocare N1 received FDA 510(k) clearance on 2022-09-16, under 510(k) number K220339.

Who is the listed applicant for Esthetic Abutments Nobel Biocare N1?

The FDA 510(k) record lists Nobel Biocare Services AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Esthetic Abutments Nobel Biocare N1?

The FDA product code for Esthetic Abutments Nobel Biocare N1 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Nobel Biocare Services AG como solicitante

K231219NobelZygoma PureSet™ Tray K220048NobelProcera Zirconia N1 Base K211109N1 TiUltra TCC Implant System K212932Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray

Dispositivos relacionados (Código: NHA)

K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLC K253999Universal 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 AB K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLC K260061BioHorizons 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.