D-LUX+ 4008-1160

GUDID 08806383568821

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

DiaDent Group International

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 ID08806383568821
NIH Device Record Key0dfd3596-bbbe-419f-aa39-ed6373264bb8
Commercial Distribution StatusIn Commercial Distribution
Brand NameD-LUX+
Version Model NumberPOWER SUPPLY (ADAPTER)
Catalog Number4008-1160
Company DUNS687789453
Company NameDiaDent Group International
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108806383568821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBZActivator, Ultraviolet, For Polymerization

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-27
Device Publish Date2021-08-19

On-Brand Devices [D-LUX+]

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

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