AccessGUDID - DEVICE: Variolink Esthetic (DVIV681493WW1)

GUDID

Device Identifier (DI) Information

Brand Name: Variolink Esthetic
Version or Model: 681493WW
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 681493WW
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DVIV681493WW1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: Variolink Esthetic LC Light, Neutral, Warm, Variolink Esthetic Try-In-Paste Light, Neutral, Warm, Total Etch, AdheSE Universal VivaPen, Liquid Strip, Optra Stick Test Pack, Cannulas Total Etch /Liquid Strip, VivaPen Brush Cannulas, VivaPen Protective Sleeves, Vivadent Applicators, Application Tips Variolink, Various accessories

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?
35870	Dental composite resin	A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	MATERIAL, TOOTH SHADE, RESIN

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 954a996e-687a-4431-b9da-c698684787c8
Public Version Date: February 01, 2019
Public Version Number: 2
DI Record Publish Date: September 27, 2018