The following data is part of a premarket notification filed by Shenzhen Xiangtong Photoelectricity Technology Co., Ltd. with the FDA for X-cera Zirconia Blanks.
| Device ID | K153767 |
| 510k Number | K153767 |
| Device Name: | X-cera Zirconia Blanks |
| Classification | Powder, Porcelain |
| Applicant | SHENZHEN XIANGTONG PHOTOELECTRICITY TECHNOLOGY CO., LTD. 2~4TH FLOOR, 1ST BUILDING, SOUTH INDUSTRIAL PARK OF HONGHUAL SOUTH INDUSTRIAL PARK OF HONGHUALING, NANSHAN DISTRICT Shenzhen, CN |
| Contact | Yongqing Chen |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-12-30 |
| Decision Date | 2016-03-29 |
| Summary: | summary |