AccessGUDID - DEVICE: VELLAmini 5% Sodium Fluoride Varnish Melon Case of 12 Boxes of 100 (D024772285)

GUDID

Device Identifier (DI) Information

Brand Name: VELLAmini 5% Sodium Fluoride Varnish Melon Case of 12 Boxes of 100
Version or Model: 772285
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 772285
Company Name: Preventech

Primary DI Number: D024772285
Issuing Agency: HIBCC
Commercial Distribution End Date: May 31, 2021
Device Count: 1200
Labeler D-U-N-S® Number*: 090735093 *Terms of Use

Device Description: VELLAmini 5% Sodium Fluoride Varnish Melon Case of 12 Boxes of 100 ea. 0.5mL unit dose packages

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):	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?
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 [?]
K140350	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4b62bdd1-e7e6-4b71-aef7-33e51e022844
Public Version Date: June 14, 2024
Public Version Number: 5
DI Record Publish Date: October 05, 2016