FDA.reportPublic FDA data

Alpha-Pro® White Varnish

Primary DI
D73540706010010
Brand
Alpha-Pro® White Varnish
Company
DENTAL TECHNOLOGIES, INC.
Model
407.0601.002
Catalog number
407.0601.002
Device description
"Alpha-Pro® White Varnish contains 5% sodium fluoride. It is used in the treatment of dental and post-operative sensitivity. Alpha-Pro White Varnish when applied practically becomes invisible, unlike traditional varnishes that cause unsightly yellow coloring of the teeth. Alpha-Pro White Varnish sets immediately on contact with saliva, leaving a smooth, thin layer. Kit Contains: 50 x 0.5ml Jars (Melon), 50 Applicator Brushes, Patient Instruction Pad, 50 ""Keep Smiling"" Stickers"
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LBHVarnish, Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K124025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K124025000ALPHA-PRO WHITE VARNISHDental Technologies, Inc.2013-09-18LBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D73540706010010PrimaryHIBCC0
D73540706020010Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
847-677-5500info@dentaltech.com

Regulatory Flags#

DUNS number
148312838
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D73550100050020Alpha-Etch® 37501.0005.002501.0005.0022016-09-23
D73550100060020Alpha-Etch® 37501.0006.002501.0006.0022016-09-23
D73550101030020Alpha-Etch® 37501.0103.002501.0103.0022016-09-23
D73550101050020Alpha-Etch® 37501.0105.002501.0105.0022016-09-23
D73550102030020Alpha-Etch® 37501.0203.002501.0203.0022016-09-23
D73550102050020Alpha-Etch® 37501.0205.002501.0205.0022016-09-23
D73550112040020Alpha-Etch® 37501.1204.002501.1204.0022016-09-23
D73550112110020Alpha-Etch® 37501.1211.002501.1211.0022016-09-23
D73550112130020Alpha-Etch® 37501.1213.002501.1213.0022016-09-23
D73550301020010ALPHA-DENT® Etchant Liquid503.0102.001503.0102.0012016-09-23
D73550301030010ALPHA-DENT® Etchant Liquid503.0103.001503.0103.0012016-09-23
D73550302030010ALPHA-DENT® Etchant Liquid503.0203.001503.0203.0012016-09-23
D73550302050010ALPHA-DENT® Etchant Liquid503.0205.001503.0205.0012016-09-23
D73520000000010ALPHA-DENT® Self Cure Bonding Adhesive200.0000.001200.0000.0012016-09-23
D73520000010010ALPHA-DENT® Self Cure Bonding Adhesive200.0001.001200.0001.0012016-09-23
D73520001020010ALPHA-DENT® Self Cure Bonding Adhesive200.0102.001200.0102.0012016-09-23
D73520002020010ALPHA-DENT® Self Cure Bonding Adhesive200.0202.001200.0202.0012016-09-23
D73520600000010ALPHA-DENT® Light Cure Bonding Adhesive206.0000.001206.0000.0012016-09-23
D73520600010010ALPHA-DENT® Light Cure Bonding Adhesive206.0001.001206.0001.0012016-09-23
D73520601010010ALPHA-DENT® Light Cure Bonding Adhesive206.0101.001206.0101.0012016-09-23

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