DEVICE: Henry Schein (00304040005101)

Device Identifier (DI) Information

Henry Schein
1011747
In Commercial Distribution
1011747
HENRY SCHEIN, INC.
00304040005101
GS1

1
012430880 *Terms of Use
ZOE Temporary Cement
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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
Temporary dental filling material A dental material of various chemical compositions [e.g., calcium hydroxide (Ca(OH)2), methyl methacrylate] used to temporarily fill tooth cavities to preserve the tooth and its pulp. It is typically x-ray visible and may be used for temporary tooth filling with direct/indirect capping, root treatment with pulp capping, vital amputations, treatment of extirpation, decayed pulps, gangrene, fistulae, sensitive tooth crevices, superficial enamel caries, and marginal periodontium inflammation. After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
EMB ZINC OXIDE EUGENOL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 10 and 24 Degrees Celsius
Storage Environment Temperature: between 10 and 75 Degrees Fahrenheit
Special Storage Condition, Specify: Keep out of sun
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Clinically Relevant Size

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Size Type Text
Weight: 45 Gram
Device Size Text, specify: Catalyst
Weight: 20 Gram
Device Size Text, specify: Base
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Device Record Status

a62f06ef-85cf-4cb3-b627-7d9840062c14
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)

[?]
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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