DEVICE: Ultra Band Lok (D798LLUBLBP0)
Device Identifier (DI) Information
Ultra Band Lok
LLUBLBP
In Commercial Distribution
LLUBLBP
RELIANCE ORTHODONTIC PRODUCTS INC
LLUBLBP
In Commercial Distribution
LLUBLBP
RELIANCE ORTHODONTIC PRODUCTS INC
Ultra Band-Lok is intended for use as an orthodontic band cement and for occlusal buildups. Ultra Band-Lok can also be used to bond brackets, lingual retainers and large acrylic appliances. This product is in Blue Shade will contrast the enamel and facilitate removal of material before and after treatment.
Luer Lok Ultra Band Lok 5g syringe Blue shade with 10 tips
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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No |
GMDN
[?]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. |
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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Special Storage Condition, Specify: Store refrigerated (2-8 Degrees C) Avoid excessive heat. Allow product to reach room temperature prior to use. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
eaf107c5-d81a-456f-9c8c-d3092ebebad5
March 29, 2018
2
August 05, 2016
March 29, 2018
2
August 05, 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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
630-773-4009
paulgropi@aol.com
paulgropi@aol.com