FDA UDI
In Commercial Distribution
🇺🇸 United States
PMMA CAD/CAM disc
DI: EPOLPMMA4610
·
Model: PMMA.461
·
POLIDENT d.o.o.
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PMMA CAD/CAM disc
- Primary DI
- EPOLPMMA4610
- Version / Model
- PMMA.461
- Catalog Number
- PMMA.461
- Company Name
- POLIDENT d.o.o.
- Labeler DUNS
- 644778409
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-07
- Public Version
- 1
- Public Version Date
- 2024-10-15
- Public Version Status
- New
- Public Device Record Key
- e962407a-4257-4bc9-99ab-1f8247e17cb5
Device Description
PMMA CAD/CAM disc A3-16-95-Z
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | Dental | 872.3770 | 2 |
| ELM | Denture, Plastic, Teeth | Dental | 872.3590 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31783 | Temporary dental crown/bridge | A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)]. | No | Active |
| 38643 | Resin artificial teeth | Prefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | EPOLPMMA4611 | HIBCC | carton box | 1 | In Commercial Distribution | |
| Primary | EPOLPMMA4610 | HIBCC |
Customer Contacts
- Phone
- +38653304840
- [email protected]