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Analog Hi Ø4.5mm
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref AN 4500 Model LABORATORY DEVICE
Identity
- Trade Name
- ANALOG HI Ø4.5MM EUDAMEDFDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Device Name
- ANALOG EUDAMEDANALOG HI Ø4.5MM FDA UDI
- Model / Reference
- AN 4500 EUDAMEDFDA UDILABORATORY DEVICE EUDAMED
- Description
- ANALOG HI Ø4.5MM FDA UDI
Identifiers
- Catalog Number
- AN 4500 FDA UDI
- Primary DI / UDI-DI
- 07899995204134 EUDAMEDFDA UDI
- Basic UDI-DI
- 999520000014JR EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P010299 ODONTOLOGICAL PROSTHESES - OTHER EUDAMED
- GMDN Term
- Dental implant analog FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental implant analog
Analog Hi Ø4.5mm by S.I.N. - Sistema DE Implante Nacional S.A. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental implant analog.
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- DYNAMIC ABUTMENT® SOLUTIONS — TALLADIUM ESPAÑA SL · Class I
- ANALOG — DENTIN IMPLANTS TECHNOLOGIES LTD · Class II
- Elos Accurate® Analog for Printed Models — Elos Medtech Pinol A/S · Class I
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- S.I.N. - Sistema DE Implante Nacional S.A.
Sources (2)
- FDA UDI c415676e-7fd4-4490-8d43-3b8c4b767a3d 34 fields · synced Oct 9, 2026
- EUDAMED 9f522026-d5d8-422c-8130-02f45ffc38c7 61 fields · synced Jun 19, 2026