Identity
- Trade Name
- Band-Lok® Blue FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- 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 and Ultra Band-Lok are a unique combination of Resin and Glass Ionomer technology. This device is NonFluoride Contents of Kit: •(4) 6gm. Syringes of Part A Blue Paste •(4) 6gm. Syringes of Part B Paste •Mixing Pads and Spatulas. FDA UDI
- Model / Reference
- NFBLB FDA UDI
- 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 and Ultra Band-Lok are a unique combination of Resin and Glass Ionomer technology. This device is NonFluoride Contents of Kit: •(4) 6gm. Syringes of Part A Blue Paste •(4) 6gm. Syringes of Part B Paste •Mixing Pads and Spatulas. FDA UDI
Identifiers
- Catalog Number
- NFBLB FDA UDI
- Primary DI / UDI-DI
- D798NFBLB0 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental composite resin
Band-Lok® Blue by Reliance Orthodontic Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Reliance Orthodontic Products, Inc.
Sources (1)
- FDA UDI de1ade90-1709-4328-8632-90801b3029fb 36 fields · synced Jun 8, 2026