FDA.reportPublic FDA data

NUPRO®

Primary DI
D0038013511
Brand
NUPRO®
Company
Dentsply Professional
Model
801351
Catalog number
801351
Device description
NUPRO® Shimmer® Polishing Paste for Dental Restorations
Published
2022-11-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
D0038013511PrimaryHIBCC0
D0038013510Unit 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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Close lid immediately after use to avoid moisture loss.
Special Storage Condition, Specify00Do not store above 25 degrees Celsius or 77 degrees Fahrenheit
Special Storage Condition, Specify00Keep out of direct sunlight.

Regulatory Flags#

DUNS number
144140845
Device count
2
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D0013032800Ceramco 33032803032802026-02-20
D0013031901Ceramco 33031903031902024-10-02
D0013032801Ceramco 33032803032802024-10-02
D0013034001Ceramco 33034003034002024-10-02
D0013034601Ceramco 33034603034602024-10-02
D0013035601Ceramco 33035603035602024-10-03
D0013035701Ceramco 33035703035702024-10-03
D0013036301Ceramco 33036303036302024-10-03
D0013038401Ceramco 33038403038402024-10-03
D0013039201Ceramco 33039203039202024-10-03
D0013050011Ceramco 33050013050012024-10-02
D0013050051Ceramco 33050053050052024-10-02
D0013050201Ceramco 33050203050202024-10-02
D0013050221Ceramco 33050223050222024-10-02
D0013051041Ceramco 33051043051042024-10-02
D0013051151Ceramco 33051153051152024-10-02
D0013051211Ceramco 33051213051212024-10-03
D0013051321Ceramco 33051323051322024-10-02
D0013051331Ceramco 33051333051332024-10-02
D0013051371Ceramco 33051373051372024-10-02

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