FDA.report

Magic Mix Pre-Polish Paste

Primary DI
D9497001111
Brand
Magic Mix Pre-Polish Paste
Company
Bioclear Matrix Systems
Model
Mint
Device description
Paste used to polish teeth after dental restoration is complete
Published
2023-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EJRAgent, Polishing, Abrasive, Oral Cavity

Product Code Classifications

CodeDeviceSpecialtyClass
EJRAgent, Polishing, Abrasive, Oral CavityDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D9497001111PrimaryHIBCC0

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
059020838
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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D949303021C0Original Posterior Matrix B SeriesB302 Clear2023-09-11
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D949303031C0Original Posterior Matrix B SeriesB303 Clear2023-09-11
D949304011B0Original Posterior Matrix M SeriesM401 Blue2023-09-11
D949304011C0Original Posterior Matrix M SeriesM401 Clear2023-09-11

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