DEVICE: Henry Schein (00304040004494)

Device Identifier (DI) Information

Henry Schein
1024668
In Commercial Distribution
1024668
HENRY SCHEIN, INC.
00304040004494
GS1

1
012430880 *Terms of Use
Natural Elegance Univ Bond
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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
Dentine adhesive A material primarily used as a bonding-promoting substance between dentine and a composite filling, restorative or luting material. It may also be used as a bonding substance to enamel. After application, this device cannot be reused.
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FDA Product Code

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

[?]
Size Type Text
Total Volume: 5 Milliliter
Device Size Text, specify: Bottle
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Device Record Status

4d150a82-5416-4620-81a0-4e5a24b286a0
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

[?]
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

[?]
No Customer Contact currently defined
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