DEVICE: Rely.a.Bondhttps://gudid.fda.gov/gudid/app/admin/udi/manageDI.xhtml?pageDataLoad (D79811GRPP0)

Device Identifier (DI) Information

Rely.a.Bondhttps://gudid.fda.gov/gudid/app/admin/udi/manageDI.xhtml?pageDataLoad
1.1GRPP
In Commercial Distribution
1.1GRPP
RELIANCE ORTHODONTIC PRODUCTS INC
D79811GRPP0
HIBCC

1
113170088 *Terms of Use
Rely•a•Bond® is intended for use in bonding metal, composite and ceramic orthodontic brackets. This is a 1.1 gm push syringe of Rely A Bond Paste.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

[?]
Product Code Product Code Name
DYH Adhesive, Bracket And Tooth Conditioner, Resin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store at room temperature (15-30 Degrees C)
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

56246bfc-132b-474c-9e00-a46a05d8b7ed
March 29, 2018
2
October 19, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
6307734009
paulgropi@aol.com
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