Identity
- Trade Name
- Diamodent FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Compatible with: 5.0mm Wide Platform (WP) NobelReplace implants Temporary Abutment, Titanium Non-Engaging, 1mm Collar, 5.4mm Profile FDA UDI
- Model / Reference
- N/A FDA UDI
- Description
- Compatible with: 5.0mm Wide Platform (WP) NobelReplace implants Temporary Abutment, Titanium Non-Engaging, 1mm Collar, 5.4mm Profile FDA UDI
Identifiers
- Catalog Number
- AC801 FDA UDI
- Primary DI / UDI-DI
- D907AC8010 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dry Heat Sterilization FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
Diamodent by Diamodent — 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
- Diamodent
Sources (1)
- FDA UDI c384cc98-b5f4-471e-a763-260834a26b16 34 fields · synced May 31, 2026