DEVICE: Aladdin (08800017900049)

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Device Identifier (DI) Information
Aladdin
Aladdin
In Commercial Distribution

DXM CO., LTD
08800017900049
GS1

1
688797315 *Terms of Use
This visible ray curing light is a device to enhance a bleaching effect by exposing a visible ray to teeth with a bleaching agent is designed to be used in dental clinics. This device emits 440 - 50nm blue visible ray by using 3 pieces of L.E.D (Light-Emitting Diode). It is a wireless type device and is convenient to move inside of the clinic. . Aladdin features are: - Easy to operate with touch switches to control the light intensity or operation time. - Easy to carry or move. Once charged, the power code is not necessary to keep plugged in during operation. - Removable parts like head, recharging unit, adapter, pole & foot. - Adjustable light intensity. Left, Center & Right LEDs have 3 grades of light intensity (High, Normal & Low). - Easy to store.
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Device Characteristics
Labeling does not contain MRI Safety Information
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GMDN

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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?
31806 Tooth-bleaching acceleration unit
A heat and/or light source intended to increase the oxidative effect of tooth bleachers (e.g., oxygen peroxide, carbamide peroxide, hydrogen peroxide) during tooth whitening dental procedures. It typically consists of a dedicated electromagnetic energy source (e.g., xenon lamp, LED), which may operate within a specific wavelength range, a laser, or an electric powered heater. The device is typically used during procedures in dental offices.
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FDA Product Code

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Product Code Product Code Name
EEG Heat Source For Bleaching Teeth
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization
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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Handling Environment Atmospheric Pressure: between 60 and 106 KiloPascal
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -10 and 45 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
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Device Record Status
534d1996-e4b5-4cf6-b2c7-c4d05901fcd2
June 28, 2023
1
June 20, 2023
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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
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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)

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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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