The following data is part of a premarket notification filed by Liaoning Upcera Co.,ltd with the FDA for Upcera Dental Zirconia Blank For Aesthetic Restoration.
| Device ID | K152175 |
| 510k Number | K152175 |
| Device Name: | Upcera Dental Zirconia Blank For Aesthetic Restoration |
| Classification | Powder, Porcelain |
| Applicant | LIAONING UPCERA CO.,LTD NO.122 XIANGHUAI ROAD, ECONOMIC DEVELOPMENT ZONE Benxi, CN 117004 |
| 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 | 2015-08-04 |
| Decision Date | 2015-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970402675035 | K152175 | 000 |
| 06970402675011 | K152175 | 000 |