FDA UDI
Not in Commercial Distribution
🇺🇸 United States
IDODENTINE
DI: 08435288443546
·
Model: DISC PINK VEINED 95/16mm
·
UNION DENTAL SA
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- IDODENTINE
- Primary DI
- 08435288443546
- Version / Model
- DISC PINK VEINED 95/16mm
- Catalog Number
- 4252Z/PV
- Company Name
- UNION DENTAL SA
- Labeler DUNS
- 462114760
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-10
- Public Version
- 5
- Public Version Date
- 2023-12-28
- Public Version Status
- Update
- Public Device Record Key
- 30482b66-a0f6-466c-962d-07bb36f054f5
- Distribution End Date
- 2023-12-27
Device Description
IDODENTINE DISC PINK VEINED 95/16mm
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 | 08435288443546 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150432 | 000 |