FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PRIMODENT
DI: EPOLPRI46B3
·
Model: PRI.46B3
·
POLIDENT d.o.o.
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- PRIMODENT
- Primary DI
- EPOLPRI46B3
- Version / Model
- PRI.46B3
- Catalog Number
- PRI.46B3
- Company Name
- POLIDENT d.o.o.
- Labeler DUNS
- 644778409
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-14
- Public Version
- 3
- Public Version Date
- 2025-01-21
- Public Version Status
- Update
- Public Device Record Key
- c0a4063a-48db-4ba7-9af2-2ccb2b71b856
- Distribution End Date
- 2025-01-21
Device Description
Resin Artificial Teeth
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Dry Heat Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ELM | Denture, plastic, teeth | Dental | 872.3590 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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). | No | Active |
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | EPOLPRI46B303 | HIBCC | plastic card | 1 | Not in Commercial Distribution | 2021-06-14 |
| Primary | EPOLPRI46B3 | HIBCC |
Customer Contacts
- Phone
- +38653304840
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 3 | Meter | |
| Device Size Text, specify | Size text |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep out of sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 40 Degrees Celsius