510(k) clearance

Firstar Dental Handpieces

FDA 510(k) source

510(k) number

K260029

Applicant

FDC Technology Industry Co.

Decision date

Oct 1, 2026

Date received

Jan 5, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

EFB

Device type

Handpiece, Air-Powered, Dental

Device class

Class I

Regulation

21 CFR 872.4200

Advisory committee

Dental

Statement or summary

Summary

Third party

N

Location

Kent, WA, US