FDA.reportPublic FDA data

PRAXIS SHINE

Primary DI
07897990399978
Brand
PRAXIS SHINE
Company
TDV DENTAL LTDA
Model
5012011001
Catalog number
5012011001
Device description
Praxis Shine – Cotton Polishing Brush - 1 unit.
Published
2026-05-18
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
EJQWheel, Polishing Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJQWheel, Polishing AgentDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07897990399978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07897990399978078979903999787897990399978

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
900580358
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07897990300103PROPHY BRUSHES501300100250130010022026-05-18
07897990300110PROPHY BRUSHES501300100350130010032026-05-18
07897990300127PROPHY BRUSHES501300100450130010042026-05-18
07897990300219PROPHY BRUSHES501300100550130010052026-05-18
07897990300233PROPHY BRUSHES501300100650130010062026-05-18
07897990300264PROPHY BRUSHES501300100750130010072026-05-18
07897990300271PROPHY BRUSHES501300100850130010082026-05-18
07897990300288PROPHY BRUSHES501300100950130010092026-05-18
07897990300295PROPHY BRUSHES501300101050130010102026-05-18
07897990300325PROPHY BRUSHES501300101150130010112026-05-18
07897990300332PROPHY BRUSHES501300101250130010122026-05-18
07897990301070PROPHY BRUSHES501300101350130010132026-05-18
07897990301087PROPHY BRUSHES501300101450130010142026-05-18
07897990301094PROPHY BRUSHES501300101550130010152026-05-18
07897990301100PROPHY BRUSHES501300101650130010162026-05-18
07897990301117PROPHY BRUSHES501300101750130010172026-05-18
07897990301124PROPHY BRUSHES501300101850130010182026-05-18
07897990301131PROPHY BRUSHES501300101950130010192026-05-18
07897990301148PROPHY BRUSHES501300102050130010202026-05-18
07897990301155PRAXIS POLISHERS501202101250120210122026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630243641123KENDADent4You AGEJQ2025-09-17
07630243641130KENDADent4You AGEJQ2025-09-17
07630243641147KENDADent4You AGEJQ2025-09-17
07630243641154KENDADent4You AGEJQ2025-09-17
07630243641161KENDADent4You AGEJQ2025-09-17
07630243641178KENDADent4You AGEJQ2025-09-17
07630243641185KENDADent4You AGEJQ2025-09-17
07630243641192KENDADent4You AGEJQ2025-09-17
07630243641208KENDADent4You AGEJQ2025-09-17
07630243641215KENDADent4You AGEJQ2025-09-17
07630243641222KENDADent4You AGEJQ2025-09-17
07630243641239KENDADent4You AGEJQ2025-09-17
07630243641246KENDADent4You AGEJQ2025-09-17
07630243641253KENDADent4You AGEJQ2025-09-17
07630243641260KENDADent4You AGEJQ2025-09-17
07630243641277KENDADent4You AGEJQ2025-09-17
07630243641284KENDADent4You AGEJQ2025-09-17
07630243641291KENDADent4You AGEJQ2025-09-17
07630243641307KENDADent4You AGEJQ2025-09-17
07630243641314KENDADent4You AGEJQ2025-09-17
07630243641321KENDADent4You AGEJQ2025-09-17
07630243641338KENDADent4You AGEJQ2025-09-17
07630243641345KENDADent4You AGEJQ2025-09-17
07630243641352KENDADent4You AGEJQ2025-09-17
07630243641369KENDADent4You AGEJQ2025-09-17
07630243641376KENDADent4You AGEJQ2025-09-17
07630243641383KENDADent4You AGEJQ2025-09-17
07630243641390KENDADent4You AGEJQ2025-09-17
07630243641420KENDADent4You AGEJQ2025-09-17
07630243641437KENDADent4You AGEJQ2025-09-17