The following data is part of a premarket notification filed by Liaoning Upcera Co.,ltd with the FDA for Tooth Shade Resin Material.
Device ID | K162323 |
510k Number | K162323 |
Device Name: | Tooth Shade Resin Material |
Classification | Material, Tooth Shade, Resin |
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 | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-08-19 |
Decision Date | 2017-01-12 |