Colour Liquid Prettau® Aquarell Incisal Blue (20 ml)
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- COLOUR LIQUID EUDAMEDColour Liquid Prettau® Aquarell Incisal Blue (20 ml) FDA UDI
- Generic Name
- Dental articulation paste/solution FDA UDI
- Device Name
- Colour Liquids EUDAMEDContent: 20 ml Water-based, for acid-free colouring with bio-pigments for depth effect in the incisal area ('fish mouth') and transparent blue ledges Colour Liquid for Prettau® zirconia water-based and acid-free for brush technique Warmer, less greyish colour shades Every brushstroke before sintering is comprehensible through bio pigments. Use only in combination with metal-free brushes FDA UDI
- Model / Reference
- FMAAxxxx EUDAMEDFMAC5903 FDA UDI
- Description
- Content: 20 ml Water-based, for acid-free colouring with bio-pigments for depth effect in the incisal area ('fish mouth') and transparent blue ledges Colour Liquid for Prettau® zirconia water-based and acid-free for brush technique Warmer, less greyish colour shades Every brushstroke before sintering is comprehensible through bio pigments. Use only in combination with metal-free brushes FDA UDI
Identifiers
- Primary DI / UDI-DI
- D800FMAAxxxx0 EUDAMEDD800FMAC5903 FDA UDI
- Basic UDI-DI
- ++D800COL0010018R EUDAMED
- Direct Marketing DI
- D800FMAAxxxx0 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 Prettau® Aquarell Incisal Blue (20 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 10d1dac6-9b0a-418b-a762-f379cec65dc0 34 fields · synced Jul 9, 2026
- EUDAMED c8023fc4-c81f-4bb5-83cc-9b411d42d23e 61 fields · synced Jul 9, 2026