Pearl Composite Luting Cement Auto-Mix System, Single Carthridge - Pearl is a self-cured, filled permanent cement - DENT ZAR, INC.

Duns Number:789664455

Device Description: Pearl is a self-cured, filled permanent cement designed for cementing conventional cast re Pearl is a self-cured, filled permanent cement designed for cementing conventional cast restorations on most vital and non-vital teeth. It also cements bonded bridges of both cast and etched (Maryland) and perforated base (Rochette) types. It is also suitable for cementing prefabricated laminate veneers, ceramic crowns, inlays, onlays, pins, posts and periodontal splinting.• Auto-mix system.• Versatile.• Predictable, controllable and reproducible working time.• Excellent biological and chemical resistance to oral environment.• Excellent adhesion to both the tooth and metal surfaces.• High compressive and diametral tensile strength.• Simplicity in application.

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More Product Details

Catalog Number

0004

Brand Name

Pearl Composite Luting Cement Auto-Mix System, Single Carthridge

Version/Model Number

0004

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

EMA

Product Code Name

Cement, Dental

Device Record Status

Public Device Record Key

6d6aa5a4-26d3-46b2-8e8d-4c663b89984b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 03, 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