AccessGUDID - DEVICE: Health-Tec Clear Fluoride Varnish (D773950100812)

GUDID

Device Identifier (DI) Information

Brand Name: Health-Tec Clear Fluoride Varnish
Version or Model: 950-10081
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 950-10081
Company Name: Dental Health Products Inc

Primary DI Number: D773950100812
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 623191194 *Terms of Use

Device Description: Health-Tec Clear Fluoride Varnish 0.5ml Melon 200 pack

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?
45232	Dental coating, tooth-desensitizing	A substance intended to be applied to exposed dentine (resulting from enamel erosion, breakage, or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and 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., gel, mouth-rinse resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. It is normally available [non-prescription] over-the-counter (OTC) for use in the home or healthcare facility. After application, this device cannot be reused.	Obsolete	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
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 0.5ml

Device Record Status

Public Device Record Key: 270dc96f-36e8-4eb8-96c0-824ac455e454
Public Version Date: February 07, 2019
Public Version Number: 3
DI Record Publish Date: January 24, 2017