DEVICE: Alpha-Pro® White Varnish (D73540705010010)

Device Identifier (DI) Information

Alpha-Pro® White Varnish
407.0501.002
In Commercial Distribution
407.0501.002
DENTAL TECHNOLOGIES, INC.
D73540705010010
HIBCC

50
148312838 *Terms of Use
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 (Bubble Gum), 50 Applicator Brushes, Patient Instruction Pad, 50 "Keep Smiling" Stickers
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental coating, tooth-desensitizing A non-sterile 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.
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FDA Product Code

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Product Code Product Code Name
LBH Varnish, Cavity
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 20 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

bb4483f7-8b4b-48ee-a213-3ea087036f8e
March 29, 2018
2
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: D73540705020010 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
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No
No CLOSE

Customer Contact

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847-677-5500
info@dentaltech.com
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