DEVICE: Accu Light Temporary Restorative (D83610141)
Device Identifier (DI) Information
Accu Light Temporary Restorative
1014
In Commercial Distribution
1014
DENT ZAR, INC.
1014
In Commercial Distribution
1014
DENT ZAR, INC.
• 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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35870 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EBG | Crown And Bridge, Temporary, Resin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ecfde431-caab-4620-8c18-949aa3e26542
March 29, 2018
2
September 03, 2016
March 29, 2018
2
September 03, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
D83610140
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined