L-SHA-Flowable Composite Syr. Sh. C1 - L-SHA-Light Cured Nano Particle Paint-On - DENT ZAR, INC.

Duns Number:789664455

Device Description: L-SHA-Light Cured Nano Particle Paint-On Restorative and Veneer Cement (Flowable Composite L-SHA-Light Cured Nano Particle Paint-On Restorative and Veneer Cement (Flowable Composite)L-SHA is recommended for cementing fabricated laminate veneers, restoring acrylic veneers and for use in Class III and Class V restorations, and for limited use in Class I restorations in premolars, and selected Class IV restorations where aesthetics are of primary importance.OUTSTANDING FEATURES OF THE MATERIALHigh adhesive strength to etched enamel without the use of bonding agents.Superior aesthetics due to well balanced opacity and light reflectance.Excellent color stability.Reduced oxygen inhibited layer contributes to the ease of finishing.Does not require refrigeration. Shelf life in excess of two years.Fast in application–one component restorative system.Excellent flow of the material facilitates application.May be cured with any dentalcuring instrument operating in the visible range.

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More Product Details

Catalog Number

0039

Brand Name

L-SHA-Flowable Composite Syr. Sh. C1

Version/Model Number

0039

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"

Yes

For Single-Use

Yes

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

cdf5e0c0-15a6-4032-b53c-48dcce34142e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 02, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DENT ZAR, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 59