Band-Lok
- Primary DI
- D798NFBL0
- Brand
- Band-Lok
- Company
- RELIANCE ORTHODONTIC PRODUCTS INC
- Model
- NFBL
- Catalog number
- NFBL
- Device description
- Band-Lok® is a two paste dual-cure adhesive intended for use as a band cement. Band-Lok Product Features: No messy Powder-Liquid Systems. Consistent mix viscosity every time Unlike Glass Monomer cements, Band-Lok does not have an aftertaste or odor. Better adhesion to enamel and band surfaces is achieved, reducing washout and preventing loose bands Four minute working time at room temperature without a frozen slab. Band-Lok is a Dual Cure cement. It can be used with or without a dental curing light. When band is placed and flash is cleaned a 20 second light activation allows full protection from moisture. Without light activation a complete set is achieved in 10 minutes. Superior Adhesion/Reduced Washout: Band-Lok is a unique combination of Resin and Glass Ionomer technology. This device is NonFluoride Contents of Kit: •(4) 6gm. Syringes of Part A Paste •(4) 6gm. Syringes of Part B Paste •Mixing Pads and Spatulas.
- Published
- 2018-11-14
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| EBF | Material, Tooth Shade, Resin |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EBF | Material, Tooth Shade, Resin | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D798NFBL0 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | TEMPERATURE LIMITATION: Store refrigerated (2-8 degrees C.) |
Regulatory Flags
- DUNS number
- 113170088
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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