FDA.reportPublic FDA data

NUPRO® Sensodyne® Prophylaxis Paste with Fluoride and NovaMin®

Primary DI
D0038015161
Brand
NUPRO® Sensodyne® Prophylaxis Paste with Fluoride and NovaMin®
Company
DENTSPLY INTERNATIONAL INC.
Model
801516
Catalog number
801516
Device description
NUPRO® Sensodyne® Prophy Paste, Spearmint, Polish, Fine/Medium, 100 Cups
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJRAgent, Polishing, Abrasive, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D0038015162PackageHIBCC4In Commercial Distribution
D0038015161PrimaryHIBCC0
D0038015160Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
DentifriceA substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Weight1.2Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)532-2855MilfordDE-Customer-Service@dentsplysirona.com

Regulatory Flags#

DUNS number
083235549
Device count
100
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D0026243451Enhance® mini Finishing System6243456243452022-04-11
D0026243551Enhance® mini Finishing System6243556243552022-04-11
D0026243651Enhance® mini Finishing System6243656243652022-04-11
D0026243751Enhance® mini Finishing System6243756243752022-10-13
D0026243851Enhance® mini Finishing System6243856243852022-04-11
D002624550001Polytrays62455000624550002022-07-07
D002624550011Polytrays62455001624550012022-07-07
D002624550021Polytrays62455002624550022022-07-07
D002624551001Polytrays62455100624551002022-07-07
D002624551011Polytrays62455101624551012022-07-07
D002624551021Polytrays62455102624551022022-07-07
D002624551031Polytrays62455103624551032022-07-07
D002624551051Polytrays62455105624551052022-07-07
D0026076071Calibra® Bio Bioceramic Luting Cement6076076076072022-04-20
D0026590301Palodent® Sectional Matrix System6590306590302019-04-02
D0026590701Palodent® Sectional Matrix System6590706590702019-04-02
D0026631001AutoMate®6631006631002019-04-02
D0013010121Ceramco® 3Powder Opaque i2/i43010122016-09-21
D0013010211Ceramco® 3Powder Opaque D23010212016-09-21
D0013010311Ceramco® 3Powder Opaque Modifier Yellow3010312016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EMICESA01Ena ShinyMICERIUM SPAEJR2025-11-07
EMICESB01Ena ShinyMICERIUM SPAEJR2025-11-07
00190707191177Ortho Technology®Ortho Organizers, Inc.EJR2025-10-23
17310236901089ProphyCare HApDirecta ABEJR2025-09-01
10304040192778Henry ScheinHENRY SCHEIN, INC.EJR2025-07-02
07615208479195VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479201VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479218VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479225VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479232VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479249VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208479379VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
07615208480054VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
TQ26126191191Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191201Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191211Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191221Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191231Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191251Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191261Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191271Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191281Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191291Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191301Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191311Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191321Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191331Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191341Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191351Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31
TQ26126191361Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EJR2024-10-31