Cleared Traditional

Star E900 Handpiece Series

K240183 · Dentalez, Inc., Stardental Division · Dental

Sep 2024

Decision

240d

Days

Class 1

Risk

About This 510(k) Submission

K240183 is an FDA 510(k) clearance for the Star E900 Handpiece Series, a Handpiece, Contra- And Right-angle Attachment, Dental (Class I — General Controls, product code EGS), submitted by Dentalez, Inc., Stardental Division (Lancaster, US). The FDA issued a Cleared decision on September 19, 2024, 240 days after receiving the submission on January 23, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K240183 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 23, 2024
Decision Date	September 19, 2024
Days to Decision	240 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF