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FDA 510(k)

Straumann InLab Validated Workflow

K-Number: K243478 · 2025-02-19

ApplicantInstitut Straumann AG
Decision Date2025-02-19
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann InLab Validated Workflow is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2025-02-19 under approval number K243478. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Institut Straumann AG. The 510(k) number is K243478.

When was Straumann InLab Validated Workflow approved by the FDA?

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

What company makes Straumann InLab Validated Workflow?

Straumann InLab Validated Workflow is manufactured by Institut Straumann AG.

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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