DEVICE: Maximum Cure (D798MC20B0)
Device Identifier (DI) Information
Maximum Cure
MC20B
In Commercial Distribution
MC20B
RELIANCE ORTHODONTIC PRODUCTS INC
MC20B
In Commercial Distribution
MC20B
RELIANCE ORTHODONTIC PRODUCTS INC
Maximum Cure® Sealants are intended for use in direct and indirect bonding of brackets and appliances. 20g Maximum Cure Sealant Resin B
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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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? |
---|---|---|---|---|
31750 | Orthodontic bracket adhesive |
A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DYH | Adhesive, Bracket And Tooth Conditioner, Resin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K880791 | 000 |
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 to reach room temperature prior to use. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6e0b7733-18c3-41dd-a73e-87f00e4464c5
July 06, 2018
3
August 05, 2016
July 06, 2018
3
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