The following data is part of a premarket notification filed by Liaoning Upcera Co.,ltd with the FDA for Upcera Dental Zirconia Blank & Dental Zirconia Pre-shaded Blank.
Device ID | K141724 |
510k Number | K141724 |
Device Name: | UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK |
Classification | Powder, Porcelain |
Applicant | LIAONING UPCERA CO.,LTD 853 DORCHESTER LN, SUITE-B New Milford, NJ 07646 |
Contact | Charles Shen |
Correspondent | Charles Shen LIAONING UPCERA CO.,LTD 853 DORCHESTER LN, SUITE-B New Milford, NJ 07646 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-06-26 |
Decision Date | 2014-10-22 |
Summary: | summary |