Guangzhou Heygears IMC., Inc. FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
UltraPrint Flexible Denture UV510(k)Aug 13, 2026Dental	Dental	510(k)Substantially Equivalent (Traditional)	Aug 13, 2026
UltraPrint-Dental Hard Splint UV510(k)Mar 2, 2026	—	510(k)Substantially Equivalent (Traditional)	Mar 2, 2026
UltraPrint-Dental Denture UV510(k)Nov 20, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	Nov 20, 2025
UltraPrint-Dental Temp C&B UV510(k)Jan 14, 2022Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jan 14, 2022