Identity
- Trade Name
- DD Bio ZX² monolith zero FDA UDI
- Generic Name
- Dental prosthesis dye FDA UDI
- Device Name
- DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirconia milling blanks for the manufacture of dental restorations. FDA UDI
- Model / Reference
- D4 FDA UDI
- Description
- DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirconia milling blanks for the manufacture of dental restorations. FDA UDI
Identifiers
- Catalog Number
- LZD066 FDA UDI
- Primary DI / UDI-DI
- EDDILZD0661 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Dental prosthesis dye FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
DD Bio ZX² monolith zero by Dental Direkt GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dental Direkt GmbH
Sources (1)
- FDA UDI 6b3e9621-b0bc-4919-b6e1-2f401a2c603a 36 fields · synced May 31, 2026