Cleared Abbreviated

Asiga DentaBASE

K243356 · Asiga Pty, Ltd. · Dental
Apr 2025
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K243356 is an FDA 510(k) clearance for the Asiga DentaBASE, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Asiga Pty, Ltd. (Alexandria, AU). The FDA issued a Cleared decision on April 11, 2025, 164 days after receiving the submission on October 29, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K243356 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 2024
Decision Date April 11, 2025
Days to Decision 164 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBI — Resin, Denture, Relining, Repairing, Rebasing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3760

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