DEVICE: Accu Light Temporary Restorative (D83610141)

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Device Identifier (DI) Information

Accu Light Temporary Restorative
1014
1014
DENT ZAR, INC.
D83610141
HIBCC
5
• Easy to apply; fast cure. • Outstanding depth of cure. • Reliable performance. • Good mechanical strength and wear resistance allows for an extended service time of up to six months. • Good biocompatibility shares the same basic chemistry with light cured cavity liners. • Easy removal. • Compatible with all known permanent restoratives and cements. • Long shelf life with no need for refrigeration. • Versatility in use; also suitable for making temporary inlays and onlays, endodontic stopping and emergency temporization.
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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
EBG Crown And Bridge, Temporary, Resin
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 03, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: D83610140 CLOSE

Direct Marking (DM)

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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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