DentaTOOTH— 510(k) K243370

Substantially Equivalent

Asiga Pty, Ltd.

FDA 510(k) clearance K243370 for DentaTOOTH, Substantially Equivalent on 2025-05-05. Applicant: Asiga Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Asiga Pty, Ltd.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2024-10-30
Decision date: 2025-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alexandria, AU

Download summary PDF View on FDA.gov ↗

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More clearances from Asiga Pty, Ltd.

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Data sourced from openFDA. This site is unofficial and independent of the FDA.