Ref-Line REF.U4B2
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Unverified
Overview
The REF-LINE resin artificial teeth device is a custom-made, partially edentulous partial denture designed for patients who require a removable replacement for one or more teeth in their lower or upper jaw. Made from a variety of materials including polymers, acrylics, ceramics, and metals, the REF-LINE offers a durable and long-lasting solution for replacing missing teeth. With its advanced features and customization options, this device is ideal for patients seeking a high-quality, reliable, and comfortable artificial tooth replacement.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberEPOLREFU4B2 | Date15 Jun 2021 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Ref-Line
- Generic Name
- Partial denture
- Model / Ref / Catalog
- REF.U4B2
- Primary DI / UDI-DI
- EPOLREFU4B2
- FDA Product Code
- ELM
- GMDN Term
- Partial denture
- Device Class
- Class II
- Regulation Number
- 872.3590
- GUDID distribution status
- Not in Commercial Distribution
- Sterilization Method
- Dry Heat Sterilization
- MRI Safety
- MR Safe
- Size
- Outer Diameter — 3 Meter
Other devices from POLIDENT d.o.o.
Properties
Other properties (13)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No