FDA.report

SCOTT'S SELECT 5% FLUORIDE VARNISH .40ml 50/bx MINT

Primary DI
D77824528151
Brand
SCOTT'S SELECT 5% FLUORIDE VARNISH .40ml 50/bx MINT
Company
SCOTT'S DENTAL SUPPLY L.L.C.
Model
245-2815
Catalog number
245-2815
Published
2017-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
D77824528151PrimaryHIBCC0
D77824528150Unit 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
Total Volume0.4Milliliter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
8009013368info@scottsdental.com

Regulatory Flags

DUNS number
137217043
Device count
50
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
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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