AccessGUDID - DEVICE: D-LUX+ (08806383568777)

GUDID

Device Identifier (DI) Information

Brand Name: D-LUX+
Version or Model: HANDPIECE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4008-1110
Company Name: DiaDent Group International

Primary DI Number: 08806383568777
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687789453 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35775	Dental/surgical polymerization lamp	A mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBZ	Activator, Ultraviolet, For Polymerization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200809	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -10 and 40 Degrees Celsius
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1792b44c-8b6c-47e9-9b1e-7e14042e5ec0
Public Version Date: August 27, 2021
Public Version Number: 1
DI Record Publish Date: August 19, 2021