DEVICE: Pearl Composite Luting Cement Syringe System, Part B Single Syringe (D83600060)

Device Identifier (DI) Information

Pearl Composite Luting Cement Syringe System, Part B Single Syringe
0006
In Commercial Distribution
0006
DENT ZAR, INC.
D83600060
HIBCC

1
789664455 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental composite resin A 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.
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FDA Product Code

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Product Code Product Code Name
EMA Cement, Dental
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FDA Premarket Submission

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Sterilization

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No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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Clinically Relevant Size

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Size Type Text
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Device Record Status

13e13b34-0278-4f54-90b9-5415e0694d11
March 29, 2018
2
September 03, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Unit of Use DI

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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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