Identity
- Trade Name
- CAD/CAM Fused Resin Crown PEEK FDA UDI
- Generic Name
- Custom-made dental crown, polymer FDA UDI
- Model / Reference
- / FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975031820641 FDA UDI
- FDA Product Code
- NSN FDA UDI
- GMDN Term
- Custom-made dental crown, polymer FDA UDI
Classification
- Device Class
- N FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Custom-made dental crown, polymer
CAD/CAM Fused Resin Crown PEEK by Beijing Yingguan Dental Technology Co., Ltd. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class N | Pending data |
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Manufacturer
- Manufacturer
- Beijing Yingguan Dental Technology Co., Ltd.
Sources (1)
- FDA UDI 4cbc632a-b2a3-4d68-a3c7-3737646982fc 32 fields · synced Jun 1, 2026