FDA.report

Band-Lok® Blue

Primary DI
D798BLB0
Brand
Band-Lok® Blue
Company
RELIANCE ORTHODONTIC PRODUCTS INC
Model
BLB
Catalog number
BLB
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 and Ultra Band-Lok are a unique combination of Resin and Glass Ionomer technology. Band-Lok is Fluoride releasing. Contents of Kit: •(4) 6gm. Syringes of Part A Blue Paste •(4) 6gm. Syringes of Part B Paste •Mixing Pads and Spatulas.
Published
2016-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D798BLB0PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental composite resinA 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

TypeLowHighCondition
Special Storage Condition, Specify00TEMPERATURE LIMITATION: Store refrigerated (2-8 degrees C.)

Sterilization Methods

Method

Contacts

PhoneEmail
6307734009paulgropi@aol.com

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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