SIC invent Dental Implant Systems
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- SICvantage TR Insertion Tool EUDAMEDSIC invent Dental Implant Systems FDA UDI
- Generic Name
- Dental implant holding endpiece, reusable FDA UDI
- Device Name
- SIC Manual Instruments EUDAMEDSICvantage TR Insertion Tool S, short FDA UDI
- Model / Reference
- 951613 EUDAMEDFDA UDI
- Description
- SICvantage TR Insertion Tool S, short FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260516875516 EUDAMEDFDA UDI
- Basic UDI-DI
- 426051687ManualInstr7Z EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental implant holding endpiece, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Dental implant holding endpiece, reusable
SIC invent Dental Implant Systems by SIC invent AG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SIC invent AG
Sources (2)
- FDA UDI 0ea5545d-855b-4458-aa02-2d877922bc39 34 fields · synced Jun 18, 2026
- EUDAMED 17d387d3-2a94-4d81-bde2-56a5601efabd 61 fields · synced Jun 18, 2026