DEVICE: Aladdin™ One Universal Hybrid Composite (D6870099105FG1)

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Device Identifier (DI) Information

Aladdin™ One Universal Hybrid Composite
0099105FG
0099105FG
DENTSPLY INTERNATIONAL INC.
D6870099105FG1
HIBCC
10
Aladdin™ One Universal Hybrid Composite Unit Dose Refill Package - A2 (10x 0.25g )
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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
Dental composite resin A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.
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FDA Product Code

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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

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Storage and Handling
Storage Environment Temperature: between 2 and 24 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight.
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 10 Unit Doses (0.25g each)
Weight: 0.25 Gram
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Device Status

In Commercial Distribution
September 23, 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
D6870099105FG2 12 D6870099105FG1 In Commercial Distribution Case
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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: D6870099105FG0 CLOSE

Direct Marking (DM)

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

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)532-2855
MilfordDE-Customer-Service@dentsplysirona.com
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