510(k) K260067

Eternal Art Porcelain Powders by Shandong Huge Dental Material Corporation — Product Code EIH

K260067 is an FDA 510(k) premarket notification submitted by Shandong Huge Dental Material Corporation for the device "Eternal Art Porcelain Powders". The FDA issued a decision of Substantially Equivalent on April 9, 2026. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Shandong Huge Dental Material Corporation has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2026
Date Received
January 9, 2026
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