The following data is part of a premarket notification filed by Shenyang Upcera Co., Ltd. with the FDA for Upcera Zirconia Blanks.
| Device ID | K093560 |
| 510k Number | K093560 |
| Device Name: | UPCERA ZIRCONIA BLANKS |
| Classification | Powder, Porcelain |
| Applicant | SHENYANG UPCERA CO., LTD. 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Contact | Stuart R Goldman |
| Correspondent | Stuart R Goldman SHENYANG UPCERA CO., LTD. 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-18 |
| Decision Date | 2010-01-28 |
| Summary: | summary |