DEVICE: EXCEL (D7981ERBSAF0)

Device Identifier (DI) Information

EXCEL
1ERBSAF
In Commercial Distribution
1ERBSAF
RELIANCE ORTHODONTIC PRODUCTS INC
D7981ERBSAF0
HIBCC

1
113170088 *Terms of Use
For the indirect technique, bonding large acrylic appliances and lingual appliances. This is a 6gm syringe of Excel Regular Part A with Fluoride. Blue Shade.
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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

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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 [?]
K875141 000
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Sterilization

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

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

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Size Type Text
No Device Sizes
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Device Record Status

da441862-a729-4b3b-b0ca-0bfffaf92f94
July 06, 2018
3
September 22, 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

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

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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

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
6307734009
PAULGROPI@AOL.COM
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