DEVICE: G-aenial™ (D6584011001)

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Device Identifier (DI) Information

G-aenial™
401100
401100
Gc America Inc.
D6584011001
HIBCC
20
G-aenial™ Sculpt Unitip Intro Kit, 20 unitips of each of (Shade A1, A2, & A3 only; 0.16mL each) & 1 G-Premio Bond Kit (5mL)
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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
Light-cured dental restorative composite resin A dental restorative material that consists of a blend of filler particles (e.g., glass, ceramic, zirconia, silica) mixed with a synthetic, photo-polymerizable, organic resin matrix [e.g., bisphenol A-glycidyl methacrylate (BISGMA), urethane dimethacrylate (UDMA)] intended to fill dental cavities or restore damaged hard dental tissue. It is typically a one-part paste, contained within an application syringe or capsule, that requires a light source of specific wavelengths (e.g., 460 to 480 nm) to initiate resin polymerization/hardening post application; it is typically available in tooth-coloured shades. After application, this device cannot be reused.
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FDA Product Code

[?]
Product Code Product Code Name
EBF MATERIAL, TOOTH SHADE, RESIN
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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 39 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 4 and 25 Degrees Celsius
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Clinically Relevant Size

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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

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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: D6584011000 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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