Identity
- Trade Name
- IMP ZYGOMATIC PLUS MT 16° Ø4,0X30,0MM FDA UDI
- Generic Name
- Screw endosteal dental implant, one-piece FDA UDI
- Device Name
- IMP ZYGOMATIC PLUS MT 16° Ø4,0X30,0MM FDA UDI
- Model / Reference
- ILMZ 4030EN FDA UDI
- Description
- IMP ZYGOMATIC PLUS MT 16° Ø4,0X30,0MM FDA UDI
Identifiers
- Catalog Number
- ILMZ 4030EN FDA UDI
- Primary DI / UDI-DI
- 07899995262943 FDA UDI
- 510(k) Number
- K231127 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 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 Zygomatic Plus Mt 16° Ø4, 0x30, 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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Cleared under the same submission
K231127 also covers:
- ABUTMENT MINI ANGLED MORSE TAPER Ø4, 8X2X 45° INDEX — S.I.N. - Sistema DE Implante Nacional S.A.
- ABUTMENT MINI ANGLED MORSE TAPER Ø4, 8X3X 45° INDEX — S.I.N. - Sistema DE Implante Nacional S.A.
- HEXAGONAL RETENTION SCREW 4 — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP ZYGOMATIC PLUS MT 16° Ø4, 0X32, 5MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP ZYGOMATIC PLUS MT 16° Ø4, 0X35, 0MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP ZYGOMATIC PLUS MT 16° Ø4, 0X37, 5MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP ZYGOMATIC PLUS MT 16° Ø4, 0X40, 0MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP ZYGOMATIC PLUS MT 16° Ø4, 0X42, 5MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP ZYGOMATIC PLUS MT 16° Ø4, 0X45, 0MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP ZYGOMATIC PLUS MT 16° Ø4, 0X47, 5MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP ZYGOMATIC PLUS MT 16° Ø4, 0X50, 0MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP ZYGOMATIC PLUS MT 16° Ø4, 0X52, 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 3a3aff81-eb2e-4ece-a4c9-b70ac65df140 35 fields · synced Jun 6, 2026