Identity
- Trade Name
- Elos Accurate® Model Analog FDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Device Name
- The product consists of the Elos Accurate® Model Analog (Analog) manufactured in biocompatible titanium alloy grade 5 ELI (TiAl6V4 ELI). FDA UDI
- Model / Reference
- MA-ATE30-1 FDA UDI
- Description
- The product consists of the Elos Accurate® Model Analog (Analog) manufactured in biocompatible titanium alloy grade 5 ELI (TiAl6V4 ELI). FDA UDI
Identifiers
- Catalog Number
- N/a FDA UDI
- Primary DI / UDI-DI
- 05712821003850 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implant analog FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Elos Accurate® Model Analog by Elos Medtech Pinol A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Elos Medtech Pinol A/S
Sources (1)
- FDA UDI 9409412f-96bd-4048-a3fe-2e27fadb3251 36 fields · synced May 31, 2026