Identity
- Trade Name
- PRIMODENT FDA UDI
- Generic Name
- Partial denture FDA UDI
- Device Name
- Resin Artificial Teeth FDA UDI
- Model / Reference
- PRV.I2D2 FDA UDI
- Description
- Resin Artificial Teeth FDA UDI
Identifiers
- Catalog Number
- PRV.I2D2 FDA UDI
- Primary DI / UDI-DI
- EPOLPRVI2D2 FDA UDI
- FDA Product Code
- ELM FDA UDI
- GMDN Term
- Partial denture FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3590 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dry Heat Sterilization FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3 Meter FDA UDI
PRIMODENT is a custom-made, removable artificial resin dental device designed to provide stable and comfortable prosthetic teeth replacements for partially edentulous patients. This single-use device is made of a variety of materials, including polymers like PMMA, PC, acrylic, ceramics, and/or metals, and can be created specifically for each patient's needs.
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
- POLIDENT d.o.o.
Sources (1)
- FDA UDI c06aea75-d36f-4428-b805-ee7bcc94738d 38 fields · synced Jul 10, 2026