510(k) K141723

UPCERA COLORING LIQUID (I AND II ) by Liaoning Upcera Co., Ltd. — Product Code EIH

K141723 is an FDA 510(k) premarket notification submitted by Liaoning Upcera Co., Ltd. for the device "UPCERA COLORING LIQUID (I AND II )". The FDA issued a decision of Substantially Equivalent on October 22, 2014. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Liaoning Upcera Co., Ltd. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2014
Date Received
June 26, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powder, Porcelain
Device Class
Class II
Regulation Number
872.6660
Review Panel
DE
Submission Type