FDA.reportPublic FDA data

SeptoWheels PX Kit: 12 wheels + 1 mandrel snap on

Primary DI
07897990328701
Brand
SeptoWheels PX Kit: 12 wheels + 1 mandrel snap on
Company
SEPTODONT SAS SPECIALITES SEPTODONT
Model
01C4000
Catalog number
01C4000
Device description
Finishing and polishing material
Published
2022-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EJQWheel, Polishing Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJQWheel, Polishing AgentDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07897990328701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07897990328701078979903287017897990328701

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive disk, single-useA dental instrument consisting of a circular flat or slightly conical sheet, which may carry or contain an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations (e.g., dentures, fillings, crowns). It is designed to be fixed at its centre to a laboratory mandrel or lathe, and/or intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
275273795
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00303620001434Septodont Multi-Use Dispenser01C20562025-05-29
14719871634322Biodentine Mixer01C072501C07252025-04-25
03760140703359RACEGEL01C050001C05002016-09-12
03760140703243CIMPAT PINK01E011001E01102016-09-12
03760140703250CIMPAT WHITE01E012001E01202016-09-12
07897990328435SeptoWedges Refill: 100 Asst. wooden wedges01C402001C40202022-12-19
07897990328459SeptoMatrix Sectional Refill: 50 assorted matrices01C401401C40142022-12-16
07897990328466SeptoMatrix Sectional Refill: 50 large matrices01C401501C40152022-12-16
07897990328473SeptoMatrix Sectional Refill: 50 medium matrices01C401601C40162022-12-16
07897990328480SeptoMatrix Sectional Refill: 50 small matrices01C401701C40172022-12-16
07897990328718SeptoPlus Mandrel Refill: 1 mandrel snap01C403101C40312022-12-19
07897990328725SeptoDiscs Kit: 120 assorted abrasive discs+ mandrel pop-on01C400101C40012022-12-16
07897990328732SeptoDiscs Refill:1/2” 50 assorted abrasive discs01C400201C40022022-12-16
07897990328749SeptoDiscs Refill:1/2” 50 coarse abrasive discs01C400301C40032022-12-16
07897990328756SeptoDiscs Refill:1/2” 50 medium abrasive discs01C400401C40042022-12-16
07897990328763SeptoDiscs Refill: 1/2” - 50 fine abrasive discs01C400501C40052022-12-16
07897990328770SeptoDiscs Refill: 1/2” - 50 extra fine abrasive discs01C400601C40062022-12-16
07897990329081SeptoWedges Refill: 100 wooden wedges n°1-yellow01C402101C40212022-12-19
07897990329098SeptoWedges Refill: 100 wooden wedges n°2-blue01C402201C40222022-12-19
07897990329104SeptoWedges Refill: 100 wooden wedges n°3-red01C402301C40232022-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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