FDA.reportPublic FDA data

RIVA STAR AQUA

Primary DI
09336472038403
Brand
RIVA STAR AQUA
Company
SDI LIMITED
Model
8800532
Catalog number
8800532
Device description
RIVA STAR AQUA BTL KT US
Published
2026-02-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
09336472038403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09336472038403093364720384039336472038403

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
753221852
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
29336472004747BENCO ADMIX510230351023032026-02-17
29336472004754BENCO SPHERICAL510236351023632026-02-17
29336472004860BENCO ADMIX512230351223032026-02-17
29336472004877BENCO SPHERICAL512236351223632026-02-17
09336472005450RIVA CEM AUTOMIX880070488007042026-02-16
09336472005474ULTRAMAT 2554604555460452026-02-16
09336472020965RIVA CEM AUTOMIX880070388007032026-02-16
09336472032203RIVA CEM880070088007002026-02-16
09336472038212RIVA STAR880050488005042026-02-16
09336472038366RIVA STAR AQUA880052788005272026-02-16
09336472038441RIVA STAR880053788005372026-02-16
D662070830158PD ADMIX400002540000252026-02-17
D662070830166PD ADMIX400002640000262026-02-17
D662070830273PD ADMIX400000540000052026-02-17
D662070830281PD ADMIX400000640000062026-02-17
D662070900258PD SPHERICAL400006540000652026-02-17
D662070900266PD SPHERICAL400006640000662026-02-17
D662070900373PD SPHERICAL400004540000452026-02-17
D662070900381PD SPHERICAL400004640000462026-02-17
09336472005535ULTRAMAT S554605755460572026-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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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
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10732224000302Crosstex InternationalCROSSTEX INTERNATIONAL, INC.LBH2023-06-20
10732224000319Crosstex InternationalCROSSTEX INTERNATIONAL, INC.LBH2023-06-20
20035000992974Toms Sensitive + Whitening Fluoride-Free Toothpaste TOM'S OF MAINE, INC.LBH2023-06-02
20810063753928Safco CleanCare Essential Prophy PasteSAFCO DENTAL SUPPLY CO.LBH2022-12-02