FDA.reportPublic FDA data

Blasting Powder

Primary DI
D949715031121
Brand
Blasting Powder
Company
Bioclear Matrix Systems
Model
Mint
Device description
Powder placed in the Blaster and used to clean biofilm from teeth.
Published
2023-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
D949715031121PrimaryHIBCC0
D9497150310Unit 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.

Regulatory Flags#

DUNS number
059020838
Device count
2
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D9498010162Black Triangle (BT) KitStudent/EM2024-12-03
D9498271712Evolve All-in-One Select KitFull2024-12-03
D9498271612Evolve All-in-One Select KitStudent/EM2024-10-22
D9499000412BT, Evolve, & DWSamples for 3M Heaters2024-08-20
D9498270912Evolve Matrix Procedure KitBrazil2024-07-10
D9495000821Bioclear InstrumentTwinRing Forceps2024-04-05
D9498271312Select Bioclear Evolve Posterior KitSelect2024-04-05
D9498271412Bioclear Evolve Posterior KitSelect Add-On Kit2024-04-05
D949112011021Bioclear Diamond WedgeSmall2023-09-16
D949112011041Bioclear Diamond WedgeSmall2023-09-16
D949112011081Bioclear Diamond WedgeSmall2023-09-16
D949112011101Bioclear Diamond WedgeSmall2023-09-16
D949112011161Bioclear Diamond WedgeSmall2023-09-16
D949112011500BG1Bioclear Diamond WedgeSmall2023-09-16
D949112011503Bioclear Diamond WedgeSmall2023-09-11
D94911201150BG1Bioclear Diamond WedgeSmall2023-09-16
D949112021021Bioclear Diamond WedgeMedium2023-09-16
D949112021041Bioclear Diamond WedgeMedium2023-09-16
D949112021081Bioclear Diamond WedgeMedium2023-09-16
D949112021101Bioclear Diamond WedgeMedium2023-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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07615208479379VivaDent Polishing PasteIVOCLAR VIVADENT AKTIENGESELLSCHAFTEJR2025-02-12
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