DEVICE: GC Fuji IX GP® (D6584250451)

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Device Identifier (DI) Information

GC Fuji IX GP®
425045
425045
Gc America Inc.
D6584250451
HIBCC
48
GC Fuji IX GP® EXTRA Capsule (48) - B1
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Glass ionomer dental cement A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.
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FDA Product Code

[?]
Product Code Product Code Name
EMA CEMENT, DENTAL
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 4 and 25 Degrees Celsius
Storage Environment Temperature: between 39 and 77 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 01, 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

[?]
Unit of Use DI Number: D6584250450 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(708)597-0900
customerservice@gcamerica.com
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