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DMAX Coloring Liquid 3R2.5-15ml
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 3R2.5-15ml
Identity
- Trade Name
- DMAX Coloring Liquid 3R2.5-15ml EUDAMEDDMAX / Confident / Chang's / CAMeleon Coloring Liquid FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- Liquid Stain for dental zirconium prosthesis EUDAMED
- Model / Reference
- 3R2.5-15ml EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809542033871 EUDAMEDFDA UDI
- Basic UDI-DI
- 880954203LD00FP EUDAMED
- 510(k) Number
- K173769 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
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
DMAX Coloring Liquid 3R2.5-15ml by DMAX 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 | 880954203LD00FP | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- DMAX Co., Ltd.
- EUDAMED SRN
- KR-MF-000020635
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 506b06b9-ff21-45e3-bbc1-87ae9159c2d9 61 fields · synced Jun 19, 2026
- FDA UDI cff3bb5a-4ee5-4077-b1c1-3742cdb3b38d 33 fields · synced May 30, 2026