Cleared Traditional

Firstar Dental Unit

K231297 · Firstar Dental Company · Dental

Jan 2025

Decision

634d

Days

Class 1

Risk

About This 510(k) Submission

K231297 is an FDA 510(k) clearance for the Firstar Dental Unit, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Firstar Dental Company (Kent, US). The FDA issued a Cleared decision on January 27, 2025, 634 days after receiving the submission on May 4, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number	K231297 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 04, 2023
Decision Date	January 27, 2025
Days to Decision	634 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF