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FDA 510(k)

Asiga DentaBASE

K-Number: K243356 · 2025-04-11

ApplicantAsiga Pty, Ltd.
Decision Date2025-04-11
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Asiga DentaBASE is a medical device manufactured by Asiga Pty, Ltd.. It received FDA 510(k) clearance on 2025-04-11 under approval number K243356. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Asiga DentaBASE?

Asiga DentaBASE is a medical device that received FDA 510(k) clearance on 2025-04-11. It is manufactured by Asiga Pty, Ltd.. The 510(k) number is K243356.

When was Asiga DentaBASE approved by the FDA?

Asiga DentaBASE received FDA 510(k) clearance on 2025-04-11, under approval number K243356.

What company makes Asiga DentaBASE?

Asiga DentaBASE is manufactured by Asiga Pty, Ltd..

What is the FDA product code for Asiga DentaBASE?

The FDA product code for Asiga DentaBASE is EBI.

Other Devices by Asiga Pty, Ltd.

K243370DentaTOOTH

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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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