FDA.report

Henry Schein

Primary DI
10304040040468
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
5700530
Catalog number
5700530
Device description
ACCLEAN ONE STEP FLUORIDE VARNISH CHERRY -50ct
Published
2017-02-14
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

Product Codes

CodeName
LBHVARNISH, CAVITY

Product Code Classifications

CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10304040040468PackageGS145In Commercial Distribution
00304040040461PrimaryGS10
20304040040465Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404004046810304040040468
00304040040461003040400404613040400404610304040040461
2030404004046520304040040465

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
Total Volume0.4Milliliter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods

Method

Regulatory Flags

DUNS number
012430880
Device count
50
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00304040187647Zirlux920006392000632026-02-04
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