Asiga DentaBASE— 510(k) K243356

Name: FDA 510(k) clearance K243356
Creator: U.S. Food and Drug Administration
Published: 2025-04-11

Substantially Equivalent

Asiga Pty, Ltd.

FDA 510(k) clearance K243356 for Asiga DentaBASE, Substantially Equivalent on 2025-04-11. Applicant: Asiga Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Asiga Pty, Ltd.
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 2024-10-29
Decision date: 2025-04-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Alexandria, AU

Download summary PDF View on FDA.gov ↗

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K243370 — DentaTOOTH2025-05-05

Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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