Identity
- Trade Name
- DD cube ONE FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- DD cube ONE are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. DD cube ONE can be used for all dental constructions with up to two bridge elements in the front and side tooth area. FDA UDI
- Model / Reference
- 98H18 FDA UDI
- Description
- DD cube ONE are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. DD cube ONE can be used for all dental constructions with up to two bridge elements in the front and side tooth area. FDA UDI
Identifiers
- Catalog Number
- G824 FDA UDI
- Primary DI / UDI-DI
- EDDIG8241 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Commercial Distribution
- 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
Dimensions & Sizes
- Size
- Height — 18 Millimeter FDA UDIOuter Diameter — 98.5 Millimeter FDA UDI
Category: Dental appliance fabrication material, ceramic
DD cube ONE by Dental Direkt GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 4ba4f1c1-22aa-4d39-8184-4adc5a8f6914 36 fields · synced Jun 1, 2026