Cleared Traditional

DentaTOOTH

K243370 · Asiga Pty, Ltd. · Dental

May 2025

Decision

187d

Days

Class 2

Risk

About This 510(k) Submission

K243370 is an FDA 510(k) clearance for the DentaTOOTH, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Asiga Pty, Ltd. (Alexandria, AU). The FDA issued a Cleared decision on May 5, 2025, 187 days after receiving the submission on October 30, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number	K243370 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 30, 2024
Decision Date	May 05, 2025
Days to Decision	187 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF