Guided Surgery Kit Epikut
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- KIT SURGICAL GUIDED EPIKUT EUDAMEDGUIDED SURGERY KIT EPIKUT FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- KIT SURGICAL GUIDED EPIKUT EUDAMEDGUIDED SURGERY KIT EPIKUT FDA UDI
- Model / Reference
- SURGICAL KIT EUDAMEDKCSEG 01I EUDAMEDKCSEG 01 FDA UDI
- Description
- GUIDED SURGERY KIT EPIKUT FDA UDI
Identifiers
- Catalog Number
- KCSEG 01 FDA UDI
- Primary DI / UDI-DI
- 07899995274670 EUDAMEDFDA UDI
- Basic UDI-DI
- 999520000077KH EUDAMED
- 510(k) Number
- K212404 FDA UDI
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- L159016 DENTAL SURGERY INSTRUMENT KITS, REUSABLE EUDAMED
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
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
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Guided Surgery Kit Epikut by S.I.N. - Sistema DE Implante Nacional S.A. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- S.I.N. - Sistema DE Implante Nacional S.A.
Sources (2)
- FDA UDI 17cabb00-1346-42f6-a943-2b20149ee0c0 35 fields · synced Jul 17, 2026
- EUDAMED 0fab2659-1937-49d4-a951-1fa9d59f4efa 61 fields · synced Jul 17, 2026