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510(k) K240672

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML) by Zhejiang Zahndent Biotechnology Co., Ltd. — Product Code EIH

K240672 is an FDA 510(k) premarket notification submitted by Zhejiang Zahndent Biotechnology Co., Ltd. for the device "Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML)". The FDA issued a decision of Substantially Equivalent on June 7, 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
June 7, 2024
Date Received
March 11, 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

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FDA data resources