Band-Lok® Blue - Band-Lok® is a two paste dual-cure adhesive - RELIANCE ORTHODONTIC PRODUCTS INC

Duns Number:113170088

Device Description: Band-Lok® is a two paste dual-cure adhesive intended for use as a band cement.Band-Lok Pro 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.

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More Product Details

Catalog Number

BLB

Brand Name

Band-Lok® Blue

Version/Model Number

BLB

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Device Record Status

Public Device Record Key

3d3063aa-daa0-49ba-9659-a7d9cf703abb

Public Version Date

July 24, 2020

Public Version Number

5

DI Record Publish Date

July 18, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RELIANCE ORTHODONTIC PRODUCTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 73
2 A medical device with a moderate to high risk that requires special controls. 279