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Zirconia Dental Ceramics
EUDAMEDFDA UDIClass IIa (EU MDR)
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Identity
- Trade Name
- Zirconia Dental Ceramics EUDAMEDFDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- Zirconia Dental Ceramics EUDAMED
- Model / Reference
- BSM-D98×12 SHTML A2 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06932195306084 EUDAMEDFDA UDI
- Basic UDI-DI
- 697558188CK0708K6 EUDAMED
- 510(k) Number
- K170894 FDA UDI
- FDA Product Code
- EIH FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6660 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
Yes
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Zirconia Dental Ceramics by Chengdu Besmile Medical Technology Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 697558188CK0708K6 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Chengdu Besmile Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025929
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 311cc6ac-5ecc-400e-b0bc-2f7c9370a51e 61 fields · synced May 31, 2026
- FDA UDI 0bc84526-6ae0-44a8-afc1-d3dbe0636df5 33 fields · synced May 30, 2026