FDA.report

Safco Protect Ultra Flouride Varnish

Primary DI
00810063755362
Brand
Safco Protect Ultra Flouride Varnish
Company
SAFCO DENTAL SUPPLY CO.
Model
1028536
Catalog number
1028536
Device description
Safco Protect Ultra Flouride Varnish, caramel, 100/box
Published
2022-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LBHVARNISH, CAVITY

Product Code Classifications

CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20810063755366PrimaryGS10
00810063755362Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2081006375536620810063755366
00810063755362008100637553628100637553620810063755362

GMDN Terms

TermDefinition
Dental coating, tooth-desensitizing, professionalA substance intended exclusively for professional use in a healthcare facility and designed to be applied to exposed dentine (resulting from enamel erosion, breakage, tooth restoration procedure or gingival recession) to treat dental hypersensitivity caused by physical, chemical, and/or 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., solution, gel, mouth-rinse, resin, varnish); it may also have antimicrobial properties or contain fluoride for caries prevention. After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
020417380
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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