D-LUX+ 4008-1161

GUDID 08806383568838

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: 08806383568838
• NIH Device Record Key: ae2d725b-c281-4b83-9d2c-8dc561369929
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-LUX+
• Version Model Number: Power Cord
• Catalog Number: 4008-1161
• 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: false
• Serial Number: false
• Manufacturing Date: true
• 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 -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 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	08806383568838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200809

FDA Product Code

• EBZ: Activator, Ultraviolet, For Polymerization

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-27
• Device Publish Date: 2021-08-19

On-Brand Devices [D-LUX+]

• 08806383580939: D-Lux+ is a dental curing light which is used for polymerization resinous dental materials.
• 08806383568845: D-Lux+ is a dental curing light which is used for polymerization resinous dental materials.
• 08806383568838: D-Lux+ is a dental curing light which is used for polymerization resinous dental materials.
• 08806383568821: D-Lux+ is a dental curing light which is used for polymerization resinous dental materials.
• 08806383568814: D-Lux+ is a dental curing light which is used for polymerization resinous dental materials.
• 08806383568807: D-Lux+ is a dental curing light which is used for polymerization resinous dental materials.
• 08806383568791: D-Lux+ is a dental curing light which is used for polymerization resinous dental materials.
• 08806383568784: D-Lux+ is a dental curing light which is used for polymerization resinous dental materials.
• 08806383568777: D-Lux+ is a dental curing light which is used for polymerization resinous dental materials.
• 08806383568760: D-Lux+ is a dental curing light which is used for polymerization resinous dental materials.