The following data is part of a premarket notification filed by Dongguan Xiangtong Co., Ltd. with the FDA for X-cera Pre-shaded Zirconia Blanks.
Device ID | K202673 |
510k Number | K202673 |
Device Name: | X-cera Pre-shaded Zirconia Blanks |
Classification | Powder, Porcelain |
Applicant | Dongguan Xiangtong Co., Ltd. No.4, Tech 9th Rd, Hi-Tech Industrial Development Zone, Songshan Lake Dongguan, CN 523808 |
Contact | Charles Shen |
Correspondent | Charles Shen Manton Business And Technology Services 37 Winding Ridge Oakland, NJ 07436 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-15 |
Decision Date | 2020-12-10 |