FDA UDI
In Commercial Distribution
🇺🇸 United States
BRIGHT TEMPORARY C&B
DI: 05206569722031
·
Model: A3, 7.5g (1:1)
·
DMP DENTAL INDUSTRY S.A.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BRIGHT TEMPORARY C&B
- Primary DI
- 05206569722031
- Version / Model
- A3, 7.5g (1:1)
- Company Name
- DMP DENTAL INDUSTRY S.A.
- Labeler DUNS
- 728534814
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-09
- Public Version
- 3
- Public Version Date
- 2022-11-14
- Public Version Status
- Update
- Public Device Record Key
- 477c73a4-59df-4873-b489-c39930d8385f
Device Description
Temporary Crown & Bridge composite
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
- 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 |
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 | 05206569722031 | GS1 |
Customer Contacts
- Phone
- +302299023041
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius