SIC invent Dental Implant Systems
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- SIC GS Sleeve EUDAMEDSIC invent Dental Implant Systems FDA UDI
- Generic Name
- Dental implantation drilling template guide-sleeve FDA UDI
- Device Name
- SIC Manual Instruments EUDAMEDSIC GS Sleeve Ø 3.1 mm FDA UDI
- Model / Reference
- 935590 EUDAMEDFDA UDI
- Description
- SIC GS Sleeve Ø 3.1 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260516872010 EUDAMEDFDA UDI
- Basic UDI-DI
- 426051687ManualInstr7Z EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L15901199 POSITIONING INSTRUMENTS FOR DENTAL DEVICES, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental implantation drilling template guide-sleeve 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
Yes
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 implantation drilling template guide-sleeve
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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Also classified as Dental implantation drilling template guide-sleeve.
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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 e7c17ef2-8d68-421d-a62a-56ce55db1c75 34 fields · synced Jun 18, 2026
- EUDAMED de892927-b18f-4e25-9c97-86abd659fe64 61 fields · synced Jun 18, 2026