The following data is part of a premarket notification filed by Zirdent New Material Co., Ltd with the FDA for Zirdent Dental Zirconia Blank & Dental Zirconia Pre-shaded Blank.
|Device Name:||Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank|
|Applicant||Zirdent New Material Co., Ltd No.101,3rd Building Of Hai Ping International Medical Device Industrial Area, No.229, Guyuan Road, Hi-tech New District Changsha, CN 410205|
Guangzhou Junyi Information Technology Co., Ltd. Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town Huangpu District, Guangzhou City, CN 510663
|CFR Regulation Number||872.6660 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|