AccessGUDID - DEVICE: SmartLite® Pro Modular LED Curing Light (D0026444041)

GUDID

Device Identifier (DI) Information

Brand Name: SmartLite® Pro Modular LED Curing Light
Version or Model: 644404
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 644404
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026444041
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: SmartLite® Pro Power Connector Refill

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
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 [?]
Premarket Submission Number Not Available/Not Released

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 -5 and 35 Degrees Celsius
Special Storage Condition, Specify: Keep dry.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c8afc38c-d98b-4119-a459-2fcf060f4a23
Public Version Date: April 15, 2022
Public Version Number: 1
DI Record Publish Date: April 07, 2022