FDA 510(k)

Elos Accurate Hybrid Base

Número K: K251497 · 2025-10-16

Data da decisão2025-10-16

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Elos Accurate Hybrid Base is the device name listed in this FDA 510(k) record. The listed applicant is Elos Medtech Pinol A/S. It received FDA 510(k) clearance on 2025-10-16 under 510(k) number K251497. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Elos Accurate Hybrid Base?

Elos Accurate Hybrid Base is a medical device that received FDA 510(k) clearance on 2025-10-16. The listed applicant is Elos Medtech Pinol A/S. The 510(k) number is K251497.

When did Elos Accurate Hybrid Base receive FDA 510(k) clearance?

Elos Accurate Hybrid Base received FDA 510(k) clearance on 2025-10-16, under 510(k) number K251497.

Who is the listed applicant for Elos Accurate Hybrid Base?

The FDA 510(k) record lists Elos Medtech Pinol A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elos Accurate Hybrid Base?

The FDA product code for Elos Accurate Hybrid Base is NHA.

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Outros registros que listam Elos Medtech Pinol A/S como candidato(a)

K253774Elos Accurate® Denture Fixation System K242025Elos Accurate® Hybrid Base™K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment K231307Elos Accurate Customized Abutment K230317Elos Accurate Hybrid Base K222044Elos Accurate Customized Abutment

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Fonte oficial

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