DEVICE: Henry Schein (00304040005101)
Device Identifier (DI) Information
Henry Schein
1011747
In Commercial Distribution
1011747
HENRY SCHEIN, INC.
1011747
In Commercial Distribution
1011747
HENRY SCHEIN, INC.
ZOE Temporary Cement
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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38778 | 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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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
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EMB | ZINC OXIDE EUGENOL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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 |
Clinically Relevant Size
[?]Size Type Text |
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Weight: 45 Gram |
Device Size Text, specify: Catalyst |
Weight: 20 Gram |
Device Size Text, specify: Base |
Device Record Status
a62f06ef-85cf-4cb3-b627-7d9840062c14
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined