Identity
- Trade Name
- IMTEC FDA UDI
- Generic Name
- Dental implant analog FDA UDI
- Device Name
- Multi-Unit Lab Analog FDA UDI
- Model / Reference
- IM-P5145 FDA UDI
- Description
- Multi-Unit Lab Analog FDA UDI
Identifiers
- Catalog Number
- P5145 FDA UDI
- Primary DI / UDI-DI
- D769P51450 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant analog FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Category: Dental implant analog
Imtec by Park Dental Research Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 (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
- Park Dental Research Corp
Sources (1)
- FDA UDI a4a257bc-eaab-46e8-939b-f0cc8741f85c 35 fields · synced May 30, 2026