DEVICE: Saturn M-Light, Self & Dual-Cure Core Build-Up Material (D83610101)
Device Identifier (DI) Information
Saturn M-Light, Self & Dual-Cure Core Build-Up Material
1010
In Commercial Distribution
1010
DENT ZAR, INC.
1010
In Commercial Distribution
1010
DENT ZAR, INC.
Saturn M-Light, Self & Dual-Cure Core Build-Up Material (1:4 Formula)
• in dual cure mode restorative pastes are mixed with accelerators, this permits complete set of the material irrespective of the thickness of the restoration, or the accessibility of light.
• Virtually unlimited working time in light-cure mode; convenient working time in self-cure mode.
• Well-balanced x-ray opacity permits easy distinguishing from tooth structure, pins and posts.
• Moldable, non sticky consistency.
• Allows one to control consistency, whenever desirable, by adding either liquid or paste-type catalyst for dual cure.
• Contains moderately hard filler for easier carving and shaping.
• Does not require refrigeration: long shelf life at ambient temperatures.
• The Standard Saturn M kit contains two shades: contrasting for easy distinguishing from tooth structure; and the natural for use under semi-transparent ceramics.
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? |
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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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FDA Product Code
[?]Product Code | Product Code Name |
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EBF | Material, Tooth Shade, 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
69fe8812-7c3a-4713-86c5-36abee0f0a72
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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Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined