DEVICE: REF-LINE (EPOLREFN6B2)
Device Identifier (DI) Information
REF-LINE
REF.N6B2
Not in Commercial Distribution
REF.N6B2
POLIDENT d.o.o.
REF.N6B2
Not in Commercial Distribution
REF.N6B2
POLIDENT d.o.o.
Resin Artificial Teeth
Device Characteristics
| MR Safe | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 17845 | Partial denture |
A custom-made, removeable, artificial replacement for one or more, but not all, teeth in the lower or upper jaw (mandible or maxilla) in a partially edentulous patient. It typically includes clasps of metal or plastic that clip onto remaining teeth for retention and stabilization. It can be made of a variety of materials including polymers [polymethylmethacrylate (PMMA), polycarbonate (PC)], acrylic, ceramics, and/or metals [e.g., base metal alloys or titanium (Ti)]. Also known as a removable partial denture (RPD).
|
Active | false |
| 38595 | Custom-made dental crown, polymer |
A device made entirely of polymer-based material with or without fibre reinforcement, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| ELM | Denture, plastic, teeth |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between -30 and 40 Degrees Celsius |
| Special Storage Condition, Specify: keep out of sunlight |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: Size text |
| Outer Diameter: 3 Meter |
Device Record Status
061758c1-cc51-4c84-a519-32c9b256d245
December 19, 2024
3
June 15, 2021
December 19, 2024
3
June 15, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| EPOLREFN6B203 | 1 | EPOLREFN6B2 | 2021-06-15 | Not in Commercial Distribution | plastic card |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+38653304840
polident@polident.si
polident@polident.si