Pearl Composite Luting Cement Syringe System, Part B Single Syringe

Primary DI
D83600060
Brand
Pearl Composite Luting Cement Syringe System, Part B Single Syringe
Company
DENT ZAR, INC.
Model
0006
Catalog number
0006
Device description
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.
Published
2016-09-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D83600060PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
789664455
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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D83600110Acorn Nano Micro Hybrid-Syringe Shade B2001100112016-09-02
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D83600130Acorn Nano Micro Hybrid-Syringe Shade B3001300132016-09-02
D83600140Acorn Nano Micro Hybrid-Syringe Shade C2001400142016-09-02
D83600150Acorn Nano Micro Hybrid-Syringe Shade D3001500152016-09-02
D83600160Acorn Nano Micro Hybrid-Syringe Shade A3.5001600162016-09-02
D83600170Acorn Nano Micro Hybrid-Syringe Shade C3001700172016-09-02
D83600180Acorn Nano Micro Hybrid-Syringe Shade B1001800182016-09-02
D83600190Acorn Nano Micro Hybrid-Syringe Incisal001900192016-09-02

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