DEVICE: Henry Schein (00304040005811)

Device Identifier (DI) Information

Henry Schein
1065167
In Commercial Distribution
1065167
HENRY SCHEIN, INC.
00304040005811
GS1

1
012430880 *Terms of Use
Ortho Bracket Adhes Kit
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Device Characteristics

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

GMDN

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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.
Dental etching solution An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
KLE AGENT, TOOTH BONDING, RESIN
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
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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: Keep out of sun
Storage Environment Temperature: between 35 and 50 Degrees Fahrenheit
Storage Environment Temperature: between 2 and 10 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Total Volume: 9 Milliliter
Device Size Text, specify: Etching Agent
Weight: 9 Gram
Device Size Text, specify: Primer
Device Size Text, specify: Single-Use Predosed Tip x 27
Weight: 0.35 Gram
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Device Record Status

136eb0c6-ccb3-4600-9d49-f99121cb8ee4
March 29, 2018
2
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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