Cleared Traditional

Star E900 Electric System

K251701 · Dentalez, Inc., Stardental Division · Dental

Jan 2026

Decision

224d

Days

Class 1

Risk

About This 510(k) Submission

K251701 is an FDA 510(k) clearance for the Star E900 Electric System, a Controller, Foot, Handpiece And Cord (Class I — General Controls, product code EBW), submitted by Dentalez, Inc., Stardental Division (Lancaster, US). The FDA issued a Cleared decision on January 12, 2026, 224 days after receiving the submission on June 2, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number	K251701 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 2025
Decision Date	January 12, 2026
Days to Decision	224 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF