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PMMA Block
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Shade:A0; Spec:98*20mm; Net Weight:175gModel Single Layer; Multi-Layer
Identity
- Trade Name
- PMMA Block EUDAMEDFDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Device Name
- PMMA BLOCK EUDAMED
- Model / Reference
- Single Layer; Multi-Layer EUDAMEDShade:A0; Spec:98*20mm; Net Weight:175g EUDAMEDShade:Pink; Spec:98*20mm; Net Weight:175g FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975187612008 EUDAMEDFDA UDI
- Basic UDI-DI
- 6975187612aSZKQG EUDAMED
- 510(k) Number
- K223706 FDA UDI
- FDA Product Code
- MQC FDA UDIEBG FDA UDIEBI FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Temporary dental crown/bridge FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Regulation Number
- 872.3770 FDA UDI872.3760 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
PMMA Block by Huliang(Shanghai)Bio-Tech Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6975187612aSZKQG | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Huliang(Shanghai)Bio-Tech Co., Ltd.
- EUDAMED SRN
- CN-MF-000013327
- Authorised Representative
- Share Info Consultant Service LLC Repräsentanzbüro DE-AR-000005133
Sources (2)
- EUDAMED 5077f51b-f09e-4020-964a-ab380ead6c81 61 fields · synced Jun 9, 2026
- FDA UDI 85f198fb-8a32-4b00-b770-6572554827c0 33 fields · synced May 29, 2026