FDA UDI
In Commercial Distribution
🇺🇸 United States
BRIGHT LIGHT FLOW
DI: 05206569000726
·
Model: A2 Opaque, 2g
·
DMP DENTAL INDUSTRY S.A.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- BRIGHT LIGHT FLOW
- Primary DI
- 05206569000726
- Version / Model
- A2 Opaque, 2g
- 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
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2023-07-21
- Public Version Status
- Update
- Public Device Record Key
- 37ba3559-15ed-4c32-84aa-b691a1592378
Device Description
Light curing, flowable, microhybrid composite. Radiopaque, resin-based dental restorative material for anterior and limited posterior restorations.
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 |
|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Dental | 872.3690 | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | Dental | 872.3765 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35870 | Dental composite resin | A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05206569876048 | GS1 | Box | 2 | In Commercial Distribution | |
| Primary | 05206569000726 | GS1 |
Customer Contacts
- Phone
- +302299023041
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius