SPEC3

GUDID 08800017901534

This dental device is a curing unit intended for polymerization of light-cured materials by dental professionals.

DXM CO., LTD

Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp Dental/surgical polymerization lamp

• Primary Device ID: 08800017901534
• NIH Device Record Key: ed2fbf75-d433-4817-9a34-df2ca833e98c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPEC3
• Version Model Number: SPEC3
• Company DUNS: 688797315
• Company Name: DXM CO., LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 106 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 60 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800017901534 [Primary]

FDA Product Code

• EBZ: Activator, Ultraviolet, For Polymerization

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08800017901534]

Moist Heat or Steam Sterilization

[08800017901534]

Moist Heat or Steam Sterilization

[08800017901534]

Moist Heat or Steam Sterilization

[08800017901534]

Moist Heat or Steam Sterilization

[08800017901534]

Moist Heat or Steam Sterilization

[08800017901534]

Moist Heat or Steam Sterilization

[08800017901534]

Moist Heat or Steam Sterilization

[08800017901534]

Moist Heat or Steam Sterilization

[08800017901534]

Moist Heat or Steam Sterilization

[08800017901534]

Moist Heat or Steam Sterilization

[08800017901534]

Moist Heat or Steam Sterilization

[08800017901534]

Moist Heat or Steam Sterilization

[08800017901534]

Moist Heat or Steam Sterilization

[08800017901534]

Moist Heat or Steam Sterilization

[08800017901534]

Moist Heat or Steam Sterilization

[08800017901534]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-07
• Device Publish Date: 2022-09-29

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