DEVICE: Ultra Band Lok (D798UBLB0)
Device Identifier (DI) Information
Ultra Band Lok
UBLB
Not in Commercial Distribution
UBLB
RELIANCE ORTHODONTIC PRODUCTS INC
UBLB
Not in Commercial Distribution
UBLB
RELIANCE ORTHODONTIC PRODUCTS INC
Ultra Band-Lok® is intended for use as an orthodontic band cement and for occlusal buildups.
This kit is blue shade.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
No | |
No |
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 |
---|---|
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 ◦C / 36-46◦F.). 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
d5e47030-fb6b-4bfb-a7fe-74dc5486b92c
October 29, 2018
4
July 27, 2016
October 29, 2018
4
July 27, 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