Hangzhou SHINING3D Dental Technology Co., Ltd. FDA Approvals

0 new drug approvals and 5 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
Dura-Crown510(k)Apr 27, 2026Dental	Dental	510(k)Substantially Equivalent (Special)	Apr 27, 2026
Dura-Arch510(k)Apr 17, 2026Dental	Dental	510(k)Substantially Equivalent (Traditional)	Apr 17, 2026
LumiCera510(k)Jan 21, 2026Dental	Dental	510(k)Substantially Equivalent (Traditional)	Jan 21, 2026
Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)510(k)Sep 23, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	Sep 23, 2025
Denture Base Resin DT20510(k)Mar 31, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	Mar 31, 2025