Firstar Dental Electric Motor— 510(k) K260027

Substantially Equivalent

FDC Technology Industry Co.

FDA 510(k) clearance K260027 for Firstar Dental Electric Motor, Substantially Equivalent on 2026-10-01. Applicant: FDC Technology Industry Co.. Device class: 1.

Summary

The Firstar Dental Electric Motor from FDC Technology Industry is filed under EBW, the product code named "Controller, Foot, Handpiece And Cord." The record doesn't give speed or torque specifications.

It's Class I under 21 CFR 872.4200, reviewed by the Dental panel as a Traditional 510(k).

FDC Technology filed from Kent, Washington. Review took 269 days (January 5 to October 1, 2026). Its Firstar Dental Handpieces (K260029) were received and decided on the same dates.

Clearance details

Applicant
FDC Technology Industry Co.
Product code
Product code EBW
Device class
Class 1
Regulation
21 CFR 872.4200
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Kent, WA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.