Not currently registered with FDA under this name

3D Global Biotech, Inc.

New Taipei City 221, Taiwan. Named as applicant on 2 dental 510(k) clearances between 2019 and 2022. No establishment is registered with FDA under this exact name today.

1 clearance in five years
Device types listed
0
Brands and models
0
510(k) clearances
22019–2022
Markets registered in
1United States
Establishments
0—
2019: 12022: 120102020

510(k) clearances per year, 2007–2026

510(k) clearances

Clearances on which FDA names 3D Global Biotech, Inc. as the applicant.

Decided510(k)DeviceDevice type
23 May 2022K212803DailyMate Orthodontic Aligner SystemNXC Sequential Aligner
30 Sep 2019K191774SmileAlign Orthodontic Aligner SystemNXC Sequential Aligner

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.