FDA UDI
In Commercial Distribution
🇺🇸 United States
ANAXDENT PMMA BLANK
DI: 08435288497051
·
Model: MONOLAYER PMMA BLANK
·
UNION DENTAL SA
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ANAXDENT PMMA BLANK
- Primary DI
- 08435288497051
- Version / Model
- MONOLAYER PMMA BLANK
- Catalog Number
- SAMPLE
- Company Name
- UNION DENTAL SA
- Labeler DUNS
- 462114760
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-11
- Public Version
- 1
- Public Version Date
- 2024-10-21
- Public Version Status
- New
- Public Device Record Key
- c6d502d4-0645-4552-b70f-4880d1489b3c
Device Description
SAMPLE ANAXDENT MONOLAYER PMMA BLANK U 20mm
Device Characteristics
- Single Use
- No
- 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
- No
- 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 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | 872.3760 | 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08435288497051 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150432 | 000 |