510(k) K240772

Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML) by Hunan Ceramaster Material Technology Co., Ltd. — Product Code EIH

K240772 is an FDA 510(k) premarket notification submitted by Hunan Ceramaster Material Technology Co., Ltd. for the device "Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)". The FDA issued a decision of Substantially Equivalent on May 20, 2024. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 2024
Date Received
March 21, 2024
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