FDA.reportPublic FDA data

IRIS

Primary DI
00366975000712
Brand
IRIS
Company
BENCO DENTAL SUPPLY CO.
Model
4846-384
Device description
Iris Varnish Kit Strawberry 30pk
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
10366975000719PackageGS156In Commercial Distribution
00366975000712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1036697500071910366975000719
00366975000712003669750007123669750007120366975000712

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
015108087
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00366975069252Sterling6308-1942026-07-14
00366975069276Sterling Surgical Motor Main Console6308-2012026-07-14
00366975069283Sterling6308-2102026-07-14
00366975069290Sterling6308-2292026-07-14
00366975069306Sterling6308-2382026-07-14
00366975000880MINIBLASTER4696-3222016-09-23
00366975013347FAS-TRACT4006-9062018-12-05
00366975001887BENCO3630-3312016-09-23
D74451864890BENCO5186-4892017-11-29
D74451864980BENCO5186-4982017-11-29
D74451865230BENCO5186-5232017-11-29
D74451865320BENCO5186-5322017-11-29
D74451865410BENCO5186-5412017-11-29
00366975001894BENCO3630-3682016-09-23
00366975001900BENCO3630-3862016-09-23
00366975001917BENCO3630-4022016-09-23
00366975032768BENCO3630-0552016-09-23
00366975070005Sterling5259-5162025-02-26
00366975069993Sterling6694-6422025-02-26
00366975058768BENCO5726-5832022-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783015591Bond-PRPREMIER DENTAL PRODUCTS COMPANYLBH2026-06-10
00348783015607Bond-PRPREMIER DENTAL PRODUCTS COMPANYLBH2026-06-10
00348783015614Bond-PRPREMIER DENTAL PRODUCTS COMPANYLBH2026-06-10
20827854027120Tom's of Maine Sensitive + Rapid Relief Toothpaste (4.5 oz)TOM'S OF MAINE, INC.LBH2025-12-15
20827854027571Tom's of Maine Sensitive + Whitening Toothpaste (4.5 oz)TOM'S OF MAINE, INC.LBH2025-12-15
506058610873033M™ Clinpro™3M COMPANYLBH2025-10-15
10818207025064ReminGelVista DentalLBH2025-10-09
07615208299373Cervitec PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2025-07-10
07615208292893Cervitec PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2025-03-20
00302730003178D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003192D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003208D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003215D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
00302730003222D-LISHYOUNG DENTAL MANUFACTURING I, LLCLBH2024-07-12
07615208474459Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2024-04-05
07615208474091Adhese UniversalIVOCLAR VIVADENT AKTIENGESELLSCHAFTLBH2024-03-25
106058610839633M™ Clinpro™3M COMPANYLBH2023-12-14
106058610839703M™ Clinpro™3M COMPANYLBH2023-12-14
106058610839873M™ Clinpro™3M COMPANYLBH2023-12-14
106058610839943M™ Clinpro™3M COMPANYLBH2023-12-14
106058610840073M™ Clinpro™3M COMPANYLBH2023-12-14
106058610840143M™ Clinpro™3M COMPANYLBH2023-12-14
106058610840213M™ Clinpro™3M COMPANYLBH2023-12-14
10810111542873FluoroCalBISCO INC.LBH2023-12-11
10810111542897FluoroCalBISCO INC.LBH2023-12-11
10371347011590Advance Dental ProductsThe Atlanta Dental Supply CompanyLBH2023-11-29
10732224005550Sparkle V Sodium Fluoride Varnish, CherryCROSSTEX INTERNATIONAL, INC.LBH2023-10-02
10732224005567Sparkle V Sodium Fluoride Varnish, CaramelCROSSTEX INTERNATIONAL, INC.LBH2023-10-02
10732224005574Sparkle V Sodium Fluoride Varnish, MelonCROSSTEX INTERNATIONAL, INC.LBH2023-10-02
10732224000302Crosstex InternationalCROSSTEX INTERNATIONAL, INC.LBH2023-06-20