FDA.reportPublic FDA data

Fluor Protector S

Primary DI
DIVO639520AL1
Brand
Fluor Protector S
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
639520AL
Catalog number
639520AL
Device description
Fluor Protector S Refill 1x7g
Published
2020-11-11
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
false

Product Codes#

Code, Name table
CodeName
LBHVARNISH, CAVITY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LBHVarnish, CavityDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
DIVO639520AL1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
448015938
Device count
1
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
DVIV687778WW0Adhese Universal DC687778WW687778WW2026-03-17
DVIV687779WW0Adhese Universal DC687779WW687779WW2026-03-17
07615208482416OptraSculpt759593AN759593AN2026-03-13
07615208482423OptraSculpt759595AN759595AN2026-03-13
07615208590500OptraSculpt760474AN760474AN2026-03-13
07615208590678OptraSculpt760475AN760475AN2026-03-13
07615208590494OptraSculpt760476AN760476AN2026-03-13
07615208482768OptraSculpt760477AN760477AN2026-03-13
07615208315349Modeling Liquids Ceramic7015887015882026-03-05
07615208338027Modeling Liquids Ceramic6733746733742026-03-05
07615208338058Modeling Liquids Ceramic6733716733712026-03-05
07615208374292Modeling Liquids Ceramic6053666053662026-03-05
07615208488401OptraSculpt683100AN683100AN2026-01-15
07615208445596OptraSculpt683069AN683069AN2026-01-15
07615208445602OptraSculpt683068AN683068AN2026-01-15
07615208486254OptraSculpt639793AN639793AN2026-01-15
07615208445947OptraSculpt639792AN639792AN2026-01-15
07615208590296Tetric CAD6921946921942026-01-13
07615208590258Tetric CAD6921936921932026-01-13
07615208590265Tetric CAD6921926921922026-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D7714227200BG0Dental CityICP, INC.LBH2026-03-24
D7714227200M0Dental CityICP, INC.LBH2026-03-24
D7714227200ML0Dental CityICP, INC.LBH2026-03-24
D771422750ML0Dental CityICP, INC.LBH2026-03-24
G402DENTOCLUDE1Dentoclude FCUMBERLAND BIOTHERAPEUTICS LLCLBH2026-03-19
09336472038212RIVA STARSDI LIMITEDLBH2026-02-16
09336472038366RIVA STAR AQUASDI LIMITEDLBH2026-02-16
09336472038403RIVA STAR AQUASDI LIMITEDLBH2026-02-16
09336472038441RIVA STARSDI LIMITEDLBH2026-02-16
00883205044068EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044075EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044082EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044099EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044105EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044112EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044129EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00883205044136EnamelastULTRADENT PRODUCTS, INC.LBH2026-02-11
00858290006970FluoriMax 2.5% NaF demo pack ELEVATE ORAL CARE, LLCLBH2026-01-28
00827854027126Tom's of Maine Sensitive + Rapid Relief Toothpaste (4.5 oz)TOM'S OF MAINE, INC.LBH2025-12-15
00827854027577Tom's of Maine Sensitive + Whitening Toothpaste (4.5 oz)TOM'S OF MAINE, INC.LBH2025-12-15
00883205044143EnamelastULTRADENT PRODUCTS, INC.LBH2025-11-14
00883205044150EnamelastULTRADENT PRODUCTS, INC.LBH2025-11-14
00883205044167EnamelastULTRADENT PRODUCTS, INC.LBH2025-11-14
00883205044174EnamelastULTRADENT PRODUCTS, INC.LBH2025-11-14
00850006606719Wonderful DentalRoses and Rubies, LLCLBH2025-09-19
00850006606726Wonderful DentalRoses and Rubies, LLCLBH2025-09-19
00883205033000EnamelastULTRADENT PRODUCTS, INC.LBH2025-08-23
00883205032829ConsepsisULTRADENT PRODUCTS, INC.LBH2025-08-19
00883205032843ConsepsisULTRADENT PRODUCTS, INC.LBH2025-08-19
07615208545753Cervitec PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2025-07-10