FDA 510(k)

Straumann InLab Validated Workflow

Número K: K243478 · 2025-02-19

Data da decisão2025-02-19

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Straumann InLab Validated Workflow is the device name listed in this FDA 510(k) record. The listed applicant is Institut Straumann AG. It received FDA 510(k) clearance on 2025-02-19 under 510(k) number K243478. 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 Straumann InLab Validated Workflow?

Straumann InLab Validated Workflow is a medical device that received FDA 510(k) clearance on 2025-02-19. The listed applicant is Institut Straumann AG. The 510(k) number is K243478.

When did Straumann InLab Validated Workflow receive FDA 510(k) clearance?

Straumann InLab Validated Workflow received FDA 510(k) clearance on 2025-02-19, under 510(k) number K243478.

Who is the listed applicant for Straumann InLab Validated Workflow?

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

What is the FDA product code for Straumann InLab Validated Workflow?

The FDA product code for Straumann InLab Validated Workflow is NHA.

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Fonte oficial

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