FDA.report

Health-Tec Clear Fluoride Varnish 0.5ml Mint 200 pack

Primary DI
D773950100802
Brand
Health-Tec Clear Fluoride Varnish 0.5ml Mint 200 pack
Company
Dental Health Products Inc
Model
950-10080
Catalog number
950-10080
Device description
Health-Tec Clear Fluoride Varnish 0.5ml Mint 200 pack
Published
2017-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LBHVarnish, Cavity

Product Code Classifications

CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D773950100803PackageHIBCC12In Commercial Distribution
D773950100802PrimaryHIBCC0
D773950100800Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental coating, tooth-desensitizingA 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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
800-626-2163mhull@dhpi.net

Regulatory Flags

DUNS number
623191194
Device count
200
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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