Identity
- Trade Name
- IMP. ZYGOMATIC HE Ø4.5XØ3.85X50MM FDA UDI
- Generic Name
- Screw endosteal dental implant, one-piece FDA UDI
- Device Name
- IMP. ZYGOMATIC HE Ø4.5XØ3.85X50MM FDA UDI
- Model / Reference
- IMZ 4150 FDA UDI
- Description
- IMP. ZYGOMATIC HE Ø4.5XØ3.85X50MM FDA UDI
Identifiers
- Catalog Number
- IMZ 4150 FDA UDI
- Primary DI / UDI-DI
- 07899995209177 FDA UDI
- 510(k) Number
- K203725 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 He Ø4.5xø3.85x50mm 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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Cleared under the same submission
K203725 also covers:
- IMP. ZYGOMATIC HE Ø4.5XØ3.85X32.5MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP. ZYGOMATIC HE Ø4.5XØ3.85X35MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP. ZYGOMATIC HE Ø4.5XØ3.85X37.5MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP. ZYGOMATIC HE Ø4.5XØ3.85X40MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP. ZYGOMATIC HE Ø4.5XØ3.85X42.5MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP. ZYGOMATIC HE Ø4.5XØ3.85X45MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP. ZYGOMATIC HE Ø4.5XØ3.85X47.5MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP. ZYGOMATIC HE Ø4.5XØ3.85X52.5MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP. ZYGOMATIC HE Ø4.5XØ3.85X55MM — S.I.N. - Sistema DE Implante Nacional S.A.
- IMP. ZYGOMATIC HE Ø4.5XØ3.85X57.5MM — 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 04f6f485-bd61-4322-82e7-f21bc1d35802 35 fields · synced May 30, 2026