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 |