Identity
- Trade Name
- DD Prefab Starter Kit FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- The DD Prefab Starter Kit SilaMill N4 contains one SilaMill N4 holder, one bar, four black M4 screws, three silver M4 screws, one screwdriver SW 3mm, three calibration bodies and three prefabs. FDA UDI
- Model / Reference
- SilaMill N4 FDA UDI
- Description
- The DD Prefab Starter Kit SilaMill N4 contains one SilaMill N4 holder, one bar, four black M4 screws, three silver M4 screws, one screwdriver SW 3mm, three calibration bodies and three prefabs. FDA UDI
Identifiers
- Catalog Number
- CAM 1101.5 FDA UDI
- Primary DI / UDI-DI
- EDDICAM110151 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
DD Prefab Starter Kit 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dental Direkt GmbH
Sources (1)
- FDA UDI a2456fbd-3ef6-4045-a320-7f940865bf4c 36 fields · synced May 31, 2026