Identity
- Trade Name
- IMP. EPIKUT MT16° Ø3,5X15,0MM FDA UDI
- Generic Name
- Screw endosteal dental implant, one-piece FDA UDI
- Device Name
- IMP. EPIKUT MT16° Ø3,5X15,0MM FDA UDI
- Model / Reference
- ILM 3515 FDA UDI
- Description
- IMP. EPIKUT MT16° Ø3,5X15,0MM FDA UDI
Identifiers
- Catalog Number
- ILM 3515 FDA UDI
- Primary DI / UDI-DI
- 07899995280893 FDA UDI
- 510(k) Number
- K222231 FDA UDI
- FDA Product Code
- FZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Screw endosteal dental implant, one-piece
Imp. Epikut Mt16° Ø3, 5x15, 0mm by S.I.N. - Sistema DE Implante Nacional S.A. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Screw endosteal dental implant, one-piece.
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- OT-F2 Prosthetics — OT medical GmbH · Class II
- Zirlux — HENRY SCHEIN, INC. · Class II
Cleared under the same submission
K222231 also covers:
- IMP. EPIKUT MT16° Ø3, 5X10, 0MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP. EPIKUT MT16° Ø3, 5X11, 5MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP. EPIKUT MT16° Ø3, 5X13, 0MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP. EPIKUT MT16° Ø3, 5X8, 5MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP. EPIKUT MT16° Ø3, 8X11, 5MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP. EPIKUT MT16° Ø3, 8X13, 0MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP. EPIKUT MT16° Ø3, 8X15, 0MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP. EPIKUT MT16° Ø3, 8X20, 0MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP. EPIKUT MT16° Ø3, 8X22, 0MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP. EPIKUT MT16° Ø3, 8X24, 0MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP. EPIKUT MT16° Ø3, 8X8, 5MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP. EPIKUT MT16° Ø4, 0X11, 5MM — S.I.N. - Sistema DE Implante Nacional S.A.
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
- S.I.N. - Sistema DE Implante Nacional S.A.
Sources (1)
- FDA UDI 11fac997-a656-4f6a-8a34-1705832c3e07 35 fields · synced Jun 6, 2026