Identity
- Trade Name
- SIC® Dental Implant Systems FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- SIC “White Star” Zirconium Oxide Abutment Ø 4.2 mm, GH 3.0 mm, burn-onable (incl. SIC Standard Fixation Screw) FDA UDI
- Model / Reference
- 936151 FDA UDI
- Description
- SIC “White Star” Zirconium Oxide Abutment Ø 4.2 mm, GH 3.0 mm, burn-onable (incl. SIC Standard Fixation Screw) FDA UDI
Identifiers
- Primary DI / UDI-DI
- ESIC9361511 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed 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
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
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
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant suprastructure, permanent, preformed
SIC® Dental Implant Systems by SIC invent AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, permanent, preformed.
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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
- SIC invent AG
Sources (1)
- FDA UDI 426c132f-37b4-4da7-92ef-62ff62b1eb48 34 fields · synced May 31, 2026