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SIC invent Dental Implant Systems
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 937248
Identity
- Trade Name
- SIC Bone Profiler Guide Pin EUDAMEDSIC invent Dental Implant Systems FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- SIC Manual Instruments EUDAMEDSIC Bone Profiler Guide Pin for SICvantage, red FDA UDI
- Model / Reference
- 937248 EUDAMEDFDA UDI
- Description
- SIC Bone Profiler Guide Pin for SICvantage, red FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260516876766 EUDAMEDFDA UDI
- Basic UDI-DI
- 426051687ManualInstr7Z EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Hungary EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
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: Surgical drill guide, reusable
SIC invent Dental Implant Systems by SIC invent AG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical drill guide, reusable.
- ORTHOFIX — Orthofix, Inc. · Class I
- Titan™ — Ascension Orthopedics, Inc. · Class I
- Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Distal Elbow Plating System — SKELETAL DYNAMICS L.L.C. · Class II
- Truliant — Exactech, Inc. · Class II
- Vantage — Exactech, Inc. · Class II
- Legion — Smith & Nephew, Inc. · Class II
- Hintermann Series — Dt Medtech, LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 ff74bd89-c4c8-4fa2-a015-91a00f8d9bee 34 fields · synced Jun 20, 2026
- EUDAMED 62e7a05b-d84e-4346-9e0f-1f4131f7ebda 61 fields · synced Jun 20, 2026