Question 1

What types of medical devices does Shanghai Coherz Technology Co., Ltd. manufacture?

Accepted Answer

Shanghai Coherz Technology Co., Ltd. specializes in thermoplastic materials used for dental appliance fabrication. These materials include heat-forming sheets and resins that are processed into custom dental devices, such as aligners or retainers, ensuring precise fit and functionality for patients.

Question 2

Where is Shanghai Coherz Technology Co., Ltd. based?

Accepted Answer

The company is based in the United States, though its origins trace back to Shanghai, China. The U.S. presence allows it to align with local regulatory requirements and market demands for dental fabrication materials.

Question 3

Which regulatory registries list devices manufactured by Shanghai Coherz Technology Co., Ltd.?

Accepted Answer

Devices from Shanghai Coherz Technology Co., Ltd. are listed in the FDA’s Unique Device Identifier (UDI) database. This inclusion confirms that their products comply with U.S. regulatory standards and are tracked for transparency and traceability in the medical device supply chain.

Question 4

How are devices from Shanghai Coherz Technology Co., Ltd. classified under U.S. regulations?

Accepted Answer

The company’s dental appliance fabrication materials, such as the Molekur series, are classified as Class I medical devices. This classification applies to low-risk products like dental thermoplastics, where general controls are sufficient to ensure safety and effectiveness without additional premarket review.

Device	Model / Reference	Registries	Class	Status
Molekur Pro	Pro-Foil-0.76	FDA UDI	Class I	Active
Molekur Express	Express-Disc-0.63-125	FDA UDI	Class I	Active
Molekur One	One-Foil-1.00	FDA UDI	Class I	Active
Molekur Express	Express-Foil-1.00	FDA UDI	Class I	Active
Molekur Express	Express-Disc-0.63-125	FDA UDI	Class I	Active
Molekur One	One-Disc-0.76-120	FDA UDI	Class I	Active
Molekur Express	Express-Disc-0.76-120	FDA UDI	Class I	Active
Molekur Express	Express-Disc-1.00-120	FDA UDI	Class I	Active
Molekur Express	Express-Disc-1.00-125	FDA UDI	Class I	Active
Molekur Express	Express-Foil-0.76	FDA UDI	Class I	Active
Molekur Express	Express-Disc-0.63-120	FDA UDI	Class I	Active
Molekur Express	Express-Disc-0.76-125	FDA UDI	Class I	Active
Molekur Express	Express-Disc-1.00-120	FDA UDI	Class I	Active
Molekur Express	Express-Foil-0.63	FDA UDI	Class I	Active
Molekur Pro	Pro-Disc-0.76-120	FDA UDI	Class I	Active
Molekur Express	Express-Disc-1.00-125	FDA UDI	Class I	Active
Molekur Express	Express-Disc-0.76-125	FDA UDI	Class I	Active
Molekur One	One-Disc-1.00-125	FDA UDI	Class I	Active
Molekur Pro	Pro-Disc-0.76-125	FDA UDI	Class I	Active
Molekur Express	Express-Disc-0.63-120	FDA UDI	Class I	Active
Molekur Express	Express-Disc-0.76-120	FDA UDI	Class I	Active
Molekur One	One-Disc-0.76-125	FDA UDI	Class I	Active
Molekur One	One-Foil-0.76	FDA UDI	Class I	Active
Molekur One	One-Disc-1.00-120	FDA UDI	Class I	Active

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