D-Lux 4004-1130

GUDID 08806383540926

D-Lux is a dental curing light which is used for polymerization resinous dental materials

DiaDent Group International

Dental/surgical polymerization lamp

• Primary Device ID: 08806383540926
• NIH Device Record Key: e1de257c-295a-4219-b4c0-58a3cbad7a42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-Lux
• Version Model Number: D-Lux LIGHT GUIDE (BLACK)
• Catalog Number: 4004-1130
• Company DUNS: 687789453
• Company Name: DiaDent Group International
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806383540926 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130163

FDA Product Code

• EBZ: Activator, Ultraviolet, For Polymerization

Sterilization

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

[08806383540926]

Moist Heat or Steam Sterilization

[08806383540926]

Moist Heat or Steam Sterilization

[08806383540926]

Moist Heat or Steam Sterilization

[08806383540926]

Moist Heat or Steam Sterilization

[08806383540926]

Moist Heat or Steam Sterilization

[08806383540926]

Moist Heat or Steam Sterilization

[08806383540926]

Moist Heat or Steam Sterilization

[08806383540926]

Moist Heat or Steam Sterilization

[08806383540926]

Moist Heat or Steam Sterilization

[08806383540926]

Moist Heat or Steam Sterilization

[08806383540926]

Moist Heat or Steam Sterilization

[08806383540926]

Moist Heat or Steam Sterilization

[08806383540926]

Moist Heat or Steam Sterilization

[08806383540926]

Moist Heat or Steam Sterilization

[08806383540926]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-03
• Device Publish Date: 2020-05-26

On-Brand Devices [D-Lux]

• 08806383552868: D-Lux is a dental curing light which is used for polymerization resinous dental materials
• 08806383540933: D-Lux is a dental curing light which is used for polymerization resinous dental materials
• 08806383540926: D-Lux is a dental curing light which is used for polymerization resinous dental materials
• 08806383540919: D-Lux is a dental curing light which is used for polymerization resinous dental materials
• 08806383540902: D-Lux is a dental curing light which is used for polymerization resinous dental materials