DEVICE: Band-Lok (D798BL0)
Device Identifier (DI) Information
Band-Lok
BL
In Commercial Distribution
BL
RELIANCE ORTHODONTIC PRODUCTS INC
BL
In Commercial Distribution
BL
RELIANCE ORTHODONTIC PRODUCTS INC
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.
Band-Lok is Fluoride releasing.
Contents of Kit:
•(4) 6gm. Syringes of Part A Paste
•(4) 6gm. Syringes of Part B Paste
•Mixing Pads and Spatulas.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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FDA Product Code
[?]Product Code | Product Code Name |
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EBF | Material, Tooth Shade, Resin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: TEMPERATURE LIMITATION: Store refrigerated (2-8 degrees C.) |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c77a894a-b096-4fb4-b18d-892796a66b19
July 24, 2020
5
July 18, 2016
July 24, 2020
5
July 18, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
6307734009
paulgropi@aol.com
paulgropi@aol.com