FDA 510(k)

Asiga DentaBASE

K-Number: K243356 · 2025-04-11

Decision Date2025-04-11

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Asiga DentaBASE is the device name listed in this FDA 510(k) record. The listed applicant is Asiga Pty, Ltd.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) 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. The listed applicant is Asiga Pty, Ltd.. The 510(k) number is K243356.

When did Asiga DentaBASE receive FDA 510(k) clearance?

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

Who is the listed applicant for Asiga DentaBASE?

The FDA 510(k) record lists Asiga Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Asiga DentaBASE?

The FDA product code for Asiga DentaBASE is EBI.

Other records listing Asiga Pty, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243370DentaTOOTH

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Official Source

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