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FDA 510(k)

Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus

Número K: K250473 · 2025-02-19

RequerenteDci International, LLC
Data da decisão2025-02-19
Código do produtoEIA
Comité consultivoDE
DecisãoSubstantially Equivalent

Resumo do dispositivo

Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus is the device name listed in this FDA 510(k) record. The listed applicant is Dci International, LLC. It received FDA 510(k) clearance on 2025-02-19 under 510(k) number K250473. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus?

Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus is a medical device that received FDA 510(k) clearance on 2025-02-19. The listed applicant is Dci International, LLC. The 510(k) number is K250473.

When did Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus receive FDA 510(k) clearance?

Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus received FDA 510(k) clearance on 2025-02-19, under 510(k) number K250473.

Who is the listed applicant for Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus?

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

What is the FDA product code for Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus?

The FDA product code for Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus is EIA.

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