FDA 510(k)

BTI Interna Dental Implant System UnicCa - Prosthetic Components

N.º K: K213106 · 2022-10-20

SolicitanteB.T.I. Biotechnology Institute, Sl.

Fecha de decisión2022-10-20

Código de productoNHA

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

BTI Interna Dental Implant System UnicCa - Prosthetic Components is the device name listed in this FDA 510(k) record. The listed applicant is B.T.I. Biotechnology Institute, Sl.. It received FDA 510(k) clearance on 2022-10-20 under 510(k) number K213106. 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 BTI Interna Dental Implant System UnicCa - Prosthetic Components?

BTI Interna Dental Implant System UnicCa - Prosthetic Components is a medical device that received FDA 510(k) clearance on 2022-10-20. The listed applicant is B.T.I. Biotechnology Institute, Sl.. The 510(k) number is K213106.

When did BTI Interna Dental Implant System UnicCa - Prosthetic Components receive FDA 510(k) clearance?

BTI Interna Dental Implant System UnicCa - Prosthetic Components received FDA 510(k) clearance on 2022-10-20, under 510(k) number K213106.

Who is the listed applicant for BTI Interna Dental Implant System UnicCa - Prosthetic Components?

The FDA 510(k) record lists B.T.I. Biotechnology Institute, Sl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BTI Interna Dental Implant System UnicCa - Prosthetic Components?

The FDA product code for BTI Interna Dental Implant System UnicCa - Prosthetic Components is NHA.

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Otros registros que enlistan a B.T.I. Biotechnology Institute, Sl. como solicitante

K240262BTI Interna 3.0 Dental Implant System UnicCa®K232750BTI Interna Prosthetic Components K231827BTI Dental Implant System UnicCa® – Aesthetic Post Abutments K211952BTI Interna Narrow/Plus Dental Implant System UnicCa K202825BTI Extra-Short Dental Implant System UnicCa K173257BTI Dental Implant System UnicCa

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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.