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Parker Quality & Compliance

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510(k) clearance

Firstar Dental Electric Motor

FDA 510(k) source

510(k) number
K260027
Applicant
FDC Technology Industry Co.
Decision date
Oct 1, 2026
Date received
Jan 5, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
EBW
Device type
Controller, Foot, Handpiece And Cord
Device class
Class I
Regulation
21 CFR 872.4200
Advisory committee
Dental
Statement or summary
Summary
Third party
N
Location
Kent, WA, US