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Dental Porcelain Powder
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref Stain/Glaze BS C18 4gRef Porcelain Powder TD BL2 20gRef Stain/Glaze BS C16 2g510(k) K232676Ref Stain/Glaze BS L3 2gRef Porcelain Powder TD A3.5 20gRef Stain/Glaze BS C18 2gRef Porcelain Powder TD BL4 20gRef Porcelain Powder E G1 20gRef Stain/Glaze BS C17 2gRef Stain/Glaze BS C10 4gRef Stain/Glaze BS C12 4gRef Porcelain Powder TD BL1 20gRef Porcelain Powder TD B1 20gRef Porcelain Powder WIN 20gRef Porcelain Powder TD A3 20gRef Stain/Glaze BS C5 6gRef Stain/Glaze BS C3 4gRef Stain/Glaze BS C7 4gRef Porcelain Powder TD 4L1.5 20gRef Porcelain Powder TD 5M1 20gRef Blending liquid H 10mlRef Stain/Glaze BS L1 4gRef Porcelain Powder CO R1 20gRef Porcelain Powder TD 0M1 20gRef Stain/Glaze BS C8 4gRef Stain/Glaze BS C14 2gRef Porcelain Powder TD 2R2.5 20gRef Stain/Glaze BS C6 2gRef Porcelain Powder NT 20gRef Stain/Glaze BS C20 2gRef Stain/Glaze BS L2 6gRef Stain/Glaze BS C4 2gRef Porcelain Powder TD 3M1 20gRef Stain/Glaze BS C3 2gRef Stain/Glaze BS C9 6gRef Stain/Glaze BS C16 6gRef Stain/Glaze BS C11 2gRef Stain/Glaze BS C12 2gRef Porcelain Powder E O2 20gRef Stain/Glaze BS C7 6gRef Stain/Glaze BS C10 6gRef Stain/Glaze BS C1 6gRef Stain/Glaze BS C5 4gRef Stain/Glaze BS C13 4gRef Stain/Glaze BS C2 6gRef Stain/Glaze BS C12 6gRef Stain/Glaze BS L4 4gRef Stain/Glaze BS C14 6gRef Stain/Glaze BS C8 6gRef Stain/Glaze BS L5 6gRef Porcelain Powder TD 4M2 20gRef Porcelain Powder TD 4L2.5 20gRef Stain/Glaze BS C7 2gRef Stain/Glaze BS C9 4gRef Porcelain Powder TD 2M3 20gRef Stain/Glaze BS C16 4gRef Stain/Glaze BS C13 6gRef Stain/Glaze BS C8 2gRef Porcelain Powder E G2 20gRef Porcelain Powder TD 0M2 20gRef Blending liquid H 20mlRef Stain/Glaze BS C19 2gRef Porcelain Powder E G3 20gRef Porcelain Powder TD 1M2 20gRef Porcelain Powder E L4 20gRef Porcelain Powder TD 2M2 20gRef Porcelain Powder TD B2 20gRef Porcelain Powder TD 1M1 20gRef Porcelain Powder TD 2L1.5 20gRef Porcelain Powder TD B4 20gRef Porcelain Powder TD 3R2.5 20gRef Porcelain Powder TD 3L1.5 20gRef Porcelain Powder TD C4 20gRef Porcelain Powder TD A1 20g
Identity
- Trade Name
- Dental Porcelain Powder EUDAMEDFDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- Dental Porcelain Powder EUDAMED
- Model / Reference
- Stain/Glaze BS C18 4g EUDAMEDPorcelain Powder TD BL2 20g EUDAMEDStain/Glaze BS C16 2g EUDAMEDStain/Glaze BS L3 2g EUDAMEDPorcelain Powder TD A3.5 20g EUDAMEDStain/Glaze BS C18 2g EUDAMEDPorcelain Powder TD BL4 20g EUDAMEDPorcelain Powder E G1 20g EUDAMEDStain/Glaze BS C17 2g EUDAMEDStain/Glaze BS C10 4g EUDAMEDStain/Glaze BS C12 4g EUDAMEDPorcelain Powder TD BL1 20g EUDAMEDPorcelain Powder TD B1 20g EUDAMEDFDA UDIPorcelain Powder WIN 20g EUDAMEDFDA UDIPorcelain Powder TD A3 20g EUDAMEDFDA UDIStain/Glaze BS C5 6g EUDAMEDFDA UDIStain/Glaze BS C3 4g EUDAMEDStain/Glaze BS C7 4g EUDAMEDPorcelain Powder TD 4L1.5 20g EUDAMEDPorcelain Powder TD 5M1 20g EUDAMEDBlending liquid H 10ml EUDAMEDFDA UDIStain/Glaze BS L1 4g EUDAMEDPorcelain Powder CO R1 20g EUDAMEDPorcelain Powder TD 0M1 20g EUDAMEDStain/Glaze BS C8 4g EUDAMEDStain/Glaze BS C14 2g EUDAMEDPorcelain Powder TD 2R2.5 20g EUDAMEDStain/Glaze BS C6 2g EUDAMEDPorcelain Powder NT 20g EUDAMEDFDA UDIStain/Glaze BS C20 2g EUDAMEDStain/Glaze BS L2 6g EUDAMEDStain/Glaze BS C4 2g EUDAMEDPorcelain Powder TD 3M1 20g EUDAMEDStain/Glaze BS C3 2g EUDAMEDStain/Glaze BS C9 6g EUDAMEDStain/Glaze BS C16 6g EUDAMEDStain/Glaze BS C11 2g EUDAMEDStain/Glaze BS C12 2g EUDAMEDPorcelain Powder E O2 20g EUDAMEDStain/Glaze BS C7 6g EUDAMEDStain/Glaze BS C10 6g EUDAMEDStain/Glaze BS C1 6g EUDAMEDStain/Glaze BS C5 4g EUDAMEDStain/Glaze BS C13 4g EUDAMEDStain/Glaze BS C2 6g EUDAMEDStain/Glaze BS C12 6g EUDAMEDStain/Glaze BS L4 4g EUDAMEDStain/Glaze BS C14 6g EUDAMEDStain/Glaze BS C8 6g EUDAMEDStain/Glaze BS L5 6g EUDAMEDPorcelain Powder TD 4M2 20g EUDAMEDPorcelain Powder TD 4L2.5 20g EUDAMEDStain/Glaze BS C7 2g EUDAMEDStain/Glaze BS C9 4g EUDAMEDPorcelain Powder TD 2M3 20g EUDAMEDStain/Glaze BS C16 4g EUDAMEDStain/Glaze BS C13 6g EUDAMEDStain/Glaze BS C8 2g EUDAMEDPorcelain Powder E G2 20g EUDAMEDPorcelain Powder TD 0M2 20g EUDAMEDBlending liquid H 20ml EUDAMEDFDA UDIStain/Glaze BS C19 2g EUDAMEDPorcelain Powder E G3 20g EUDAMEDPorcelain Powder TD 1M2 20g EUDAMEDPorcelain Powder E L4 20g EUDAMEDPorcelain Powder TD 2M2 20g EUDAMEDFDA UDIPorcelain Powder TD B2 20g EUDAMEDPorcelain Powder TD 1M1 20g EUDAMEDPorcelain Powder TD 2L1.5 20g EUDAMEDPorcelain Powder TD B4 20g EUDAMEDPorcelain Powder TD 3R2.5 20g EUDAMEDPorcelain Powder TD 3L1.5 20g EUDAMEDPorcelain Powder TD C4 20g EUDAMEDPorcelain Powder TD A1 20g EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06932195341009 EUDAMED06932195335336 EUDAMED06932195340842 EUDAMED06932195339150 EUDAMED06932195324361 EUDAMED06932195340996 EUDAMED06932195335398 EUDAMED06932195338276 EUDAMED06932195340910 EUDAMED06932195325269 EUDAMED06932195325283 EUDAMED06932195335305 EUDAMED06932195324385 EUDAMEDFDA UDI06932195324309 EUDAMEDFDA UDI06932195324354 EUDAMEDFDA UDI06932195340088 EUDAMEDFDA UDI06932195325191 EUDAMED06932195325238 EUDAMED06932195324651 EUDAMED06932195324729 EUDAMED06932195325344 EUDAMEDFDA UDI06932195339006 EUDAMED06932195338788 EUDAMED06932195335213 EUDAMED06932195325245 EUDAMED06932195340705 EUDAMED06932195324576 EUDAMED06932195340149 EUDAMED06932195324293 EUDAMEDFDA UDI06932195341153 EUDAMED06932195339099 EUDAMED06932195340002 EUDAMED06932195324606 EUDAMED06932195339938 EUDAMED06932195340361 EUDAMED06932195340859 EUDAMED06932195340491 EUDAMED06932195340569 EUDAMED06932195336296 EUDAMED06932195340224 EUDAMED06932195340439 EUDAMED06932195339808 EUDAMED06932195325214 EUDAMED06932195325290 EUDAMED06932195339877 EUDAMED06932195340576 EUDAMED06932195339242 EUDAMED06932195340712 EUDAMED06932195340293 EUDAMED06932195339334 EUDAMED06932195324682 EUDAMED06932195324668 EUDAMED06932195340217 EUDAMED06932195325252 EUDAMED06932195324552 EUDAMED06932195325320 EUDAMED06932195340644 EUDAMED06932195340286 EUDAMED06932195338306 EUDAMED06932195335244 EUDAMED06932195341221 EUDAMEDFDA UDI06932195341078 EUDAMED06932195338337 EUDAMED06932195324507 EUDAMED06932195336654 EUDAMED06932195324545 EUDAMEDFDA UDI06932195324392 EUDAMED06932195324491 EUDAMED06932195324514 EUDAMED06932195324415 EUDAMED06932195324644 EUDAMED06932195324583 EUDAMED06932195324453 EUDAMED06932195324330 EUDAMEDFDA UDI
- Basic UDI-DI
- 697558188CF0708HF EUDAMED
- 510(k) Number
- K232676 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 EUDAMEDHungary 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
Dental Porcelain Powder by Chengdu Besmile Medical Technology Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232676 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697558188CF0708HF | Class IIa | Active |
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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 (158)
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