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.• 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.
Catalog Number
0006
Brand Name
Pearl Composite Luting Cement Syringe System, Part B Single Syringe
Version/Model Number
0006
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
EMA
Product Code Name
Cement, Dental
Public Device Record Key
13e13b34-0278-4f54-90b9-5415e0694d11
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 03, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |