Dental Device Guide
Add your company

Not currently registered with FDA under this name

Pac-Dent International (Suzhou), Ltd.

Walnut, CA, United States. Named as applicant on 1 dental 510(k) clearance between 2004 and 2004. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
12004–2004
Markets registered in
1United States
Establishments
0—
2004: 1200020102020

510(k) clearances per year, 2000–2026

510(k) clearances

Clearances on which FDA names Pac-Dent International (Suzhou), Ltd. as the applicant.

Decided510(k)DeviceDevice type
29 Jan 2004K033120SCALETRON PIEZO ULTRASOUND SCALERELC Ultrasonic Scaler

Sources

FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.