AccessGUDID - DEVICE: Variolink Esthetic (07615208295962)

GUDID

Device Identifier (DI) Information

Brand Name: Variolink Esthetic
Version or Model: 666065WW
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 666065WW
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: 07615208295962
Issuing Agency: GS1
Commercial Distribution End Date: January 16, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 448015938 *Terms of Use
Previous DI: DVIV666065WW1

Device Description: Variolink Esthetic LC System Kit

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: 405ae335-09d0-4ebe-86ab-4992f949f0a5
Public Version Date: January 17, 2025
Public Version Number: 2
DI Record Publish Date: March 29, 2023