AccessGUDID - DEVICE: Varnish America (00302730002430)

GUDID

Device Identifier (DI) Information

Brand Name: Varnish America
Version or Model: 07-0130
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 07-0130
Company Name: YOUNG DENTAL MANUFACTURING I, LLC

Primary DI Number: 00302730002430
Issuing Agency: GS1
Commercial Distribution End Date: September 10, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 006309355 *Terms of Use

Device Description: VarnishAmerica 5% Sodium Fluoride Varnish, 0.25mL each, White Bubblegum, with Xylitol - Includes Blue Ultrabrush

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:	Yes
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?
64794	Dental coating, tooth-desensitizing, professional	A substance intended exclusively for professional use in a healthcare facility and designed to be applied to exposed dentine (resulting from enamel erosion, breakage, tooth restoration procedure or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and/or physiological agents (e.g., cold, heat, contact, acid, bruxism) by forming a barrier within the dentine tubules. It is a mixture of synthetic and/or plant-derived ingredients in fluid form (e.g., solution, gel, mouth-rinse, resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LBH	VARNISH, CAVITY

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: 5c37fca4-6716-4b05-a282-2020852aac7f
Public Version Date: September 11, 2024
Public Version Number: 3
DI Record Publish Date: October 16, 2022