MedtechSourcebook

GC AMERICA INC.

Contract manufacturer · Alsip, IL

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
1410097 (openFDA record; or search FDA's registration database)
FEI number
1410097
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Manufacturer; Contract manufacturer; Remanufacturer; Repackager or relabeler
Owner or operator
GC America Inc. (FDA owner/operator no. 8030268)
Registered address
3737 W 127th St, Alsip, IL 60803
Contract listings
1 device listings, 1 product codes, first listed Apr 18, 2024
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
NXCAligner, SequentialClass IIDentalContract manufacturingApr 18, 2024