Colour Liquid Aquarell Bio-Pigment Violet (10 ml)
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- COLOUR LIQUID AQUARELL BIO-PIGMENT EUDAMEDColour Liquid Aquarell Bio-Pigment Violet (10 ml) FDA UDI
- Generic Name
- Dental articulation paste/solution FDA UDI
- Device Name
- Colour Liquids EUDAMEDContent: 10 ml Burn-out pigments for freshening up Colour Liquid Prettau® Aquarell Incisal Violet FDA UDI
- Model / Reference
- FMADxxxx EUDAMEDFMAD0060 FDA UDI
- Description
- Content: 10 ml Burn-out pigments for freshening up Colour Liquid Prettau® Aquarell Incisal Violet FDA UDI
Identifiers
- Primary DI / UDI-DI
- D800FMADxxxx0 EUDAMEDD800FMAD0060 FDA UDI
- Basic UDI-DI
- ++D800COL0040019E EUDAMED
- Direct Marketing DI
- D800FMADxxxx0 EUDAMED
- FDA Product Code
- EIH FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental articulation paste/solution 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
Single Use
No
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Dental articulation paste/solution
Colour Liquid Aquarell Bio-Pigment Violet (10 ml) by Zirkonzahn GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Zirkonzahn GmbH
Sources (2)
- FDA UDI 3fa34175-59bc-4198-bde6-ecc9f75bd8d5 34 fields · synced Jul 11, 2026
- EUDAMED 0138a786-78d1-4919-9e20-5ffbf12fb415 61 fields · synced Jul 11, 2026