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Imp. Epikut Plus Mt16° Ø4, 5x8, 5mm
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref ILM 4511NModel DENTAL IMPLANTS WITH HYDROXYAPATITE
Identity
- Trade Name
- IMP. EPIKUT S PLUS MT16° Ø4.5X11.5MM EUDAMEDIMP. EPIKUT PLUS MT16° Ø4,5X8,5MM FDA UDI
- Generic Name
- Screw endosteal dental implant, one-piece FDA UDI
- Device Name
- IMPLANT STRONG SW PLUS | IMPLANT UNITITE | IMPLANT EPIKUT PLUS EUDAMEDIMP. EPIKUT PLUS MT16° Ø4,5X8,5MM FDA UDI
- Model / Reference
- DENTAL IMPLANTS WITH HYDROXYAPATITE EUDAMEDILM 4511N EUDAMEDILM 4585N FDA UDI
- Description
- IMP. EPIKUT PLUS MT16° Ø4,5X8,5MM FDA UDI
Identifiers
- Catalog Number
- ILM 4585N FDA UDI
- Primary DI / UDI-DI
- 07899995274045 EUDAMEDFDA UDI
- Basic UDI-DI
- 999520000002JJ EUDAMED
- 510(k) Number
- K222231 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Screw endosteal dental implant, one-piece FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
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
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 Plus Mt16° Ø4, 5x8, 5mm by S.I.N. - Sistema DE Implante Nacional S.A. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Screw endosteal dental implant, one-piece.
- Infinity External Hex System — ACE SURGICAL SUPPLY CO., INC. · Class II
- KJ Mini Implant System — Kj Meditech · Class II
- Zirlux — HENRY SCHEIN, INC. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- KJ Mini Implant System — Kj Meditech · Class II
- Advanced Intermezzo Fixture — Megagen Implant Co. Ltd · Class II
- 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, 5X15, 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.
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 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 d9da2d1d-ce12-4756-83a3-6e4924d604c0 35 fields · synced Oct 7, 2026
- EUDAMED b983b305-8313-477f-9ad4-2704be9d2bf3 61 fields · synced Oct 7, 2026