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Pre-Sintered Zirconia Coloring Liquid
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 4M3 20ml
Identity
- Trade Name
- Pre-Sintered Zirconia Coloring Liquid EUDAMEDFDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- Pre-Sintered Zirconia Coloring Liquid EUDAMED
- Model / Reference
- 4M3 20ml EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06932195328208 EUDAMEDFDA UDI
- Basic UDI-DI
- 697558188RSY0708C6 EUDAMED
- 510(k) Number
- K232682 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
No
EUDAMEDFDA UDIEUDAMED
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Pre-Sintered Zirconia Coloring Liquid 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 | 697558188RSY0708C6 | 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 (3)
- EUDAMED 55a2401a-ea04-4761-bc3f-db8d8267f140 61 fields · synced Jun 18, 2026
- FDA UDI 4eee1ea0-1502-458a-9888-4368804d6378 33 fields · synced May 30, 2026
- EUDAMED de45aa2e-d630-4462-8ee5-47ea497d5b99 61 fields · synced Jun 18, 2026