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Sign in to claim this brandNissin-Metec China Co., Ltd.
US
Last updated May 23, 2026
What Nissin-Metec China Co., Ltd. makes
The company produces dental porcelain and ceramic restoration kits, including zirconia blanks and pre-shaded zirconia blanks for dental applications.
These products are classified as Class II devices and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Nissin-Metec China Co., Ltd. manufacture?
Nissin-Metec China Co., Ltd. specializes in dental porcelain and ceramic restoration kits. Their primary focus is on zirconia-based products, such as zirconia blanks and pre-shaded zirconia blanks, which are used in dental restorations like crowns, bridges, and inlays.
Where is Nissin-Metec China Co., Ltd. based?
The company is based in the United States. While the name includes 'China,' the operational headquarters and manufacturing presence for these devices are located in the US.
Which regulatory registries list the devices made by Nissin-Metec China Co., Ltd.?
The devices produced by Nissin-Metec China Co., Ltd. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their dental porcelain and ceramic restoration kits, including zirconia blanks.
How are the devices manufactured by Nissin-Metec China Co., Ltd. classified under regulatory standards?
The dental porcelain and ceramic restoration kits produced by Nissin-Metec China Co., Ltd. fall under Class II device classification. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as pre-market notification (510(k)) clearance in the US.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 543006823
Catalogue (505)
Page 11 of 11| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | 70×40×16（T0） | FDA UDI | Class II | Active |
| Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | 72×41×12（B2） | FDA UDI | Class II | Active |
| Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | 72×41×24（T0） | FDA UDI | Class II | Active |
| Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | D98×25（A2） | FDA UDI | Class II | Active |
| Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | K160367 | FDA 510(k) | Class II | Active |
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