Question 1

What types of medical devices does Zhejiang Zahndent Biotechnology Co., Ltd manufacture?

Accepted Answer

Zhejiang Zahndent Biotechnology Co., Ltd specializes in dental appliance fabrication materials, specifically zirconia blanks and pre-shaded zirconia blanks. These materials are primarily used in dental restorations, such as milling and shaping into crowns, bridges, or other dental prosthetics. The focus is on providing both structural integrity and aesthetic versatility for dental professionals.

Question 2

Where is Zhejiang Zahndent Biotechnology Co., Ltd based?

Accepted Answer

The company is based in the United States. This location is relevant for regulatory compliance and distribution within the U.S. market, where its devices are authorized and listed.

Question 3

Which regulatory registries list the devices manufactured by Zhejiang Zahndent Biotechnology Co., Ltd?

Accepted Answer

The devices produced by Zhejiang Zahndent Biotechnology Co., Ltd are listed in the FDA’s Unique Device Identification (UDI) database. This registry ensures traceability and compliance with U.S. regulatory standards for Class II medical devices, which includes their zirconia blanks and pre-shaded zirconia blanks.

Question 4

How are the devices manufactured by Zhejiang Zahndent Biotechnology Co., Ltd classified under U.S. regulations?

Accepted Answer

The devices manufactured by Zhejiang Zahndent Biotechnology Co., Ltd are classified as Class II medical devices under U.S. regulations. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as dental restorative materials like zirconia blanks.

Device	Model / Reference	Registries	Class	Status
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank	ZD-ST	FDA UDI	Class II	Active
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank	ZD-ST-C	FDA UDI	Class II	Active
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank	ZD-HT-C	FDA UDI	Class II	Active
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank	ZD-SHT	FDA UDI	Class II	Active
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank	ZD-3D-Pro-ML	FDA UDI	Class II	Active
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank	ZD-UT-ML	FDA UDI	Class II	Active
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank	ZD-UT-C	FDA UDI	Class II	Active
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank	ZD-SHT-C	FDA UDI	Class II	Active
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank	ZD-4D-Pro-ML	FDA UDI	Class II	Active
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank	ZD-HT-PLUS	FDA UDI	Class II	Active
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank	ZD-SHT-ML	FDA UDI	Class II	Active
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank	ZD-ST-ML	FDA UDI	Class II	Active

ZHEJIANG ZAHNDENT BIOTECHNOLOGY CO., LTD

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