FDA.reportPublic FDA data

PRAXIS DIAMOND

Primary DI
07897990399756
Brand
PRAXIS DIAMOND
Company
TDV DENTAL LTDA
Model
5012001000
Catalog number
5012001000
Device description
Praxis Diamond Occlusal CA Medium - 1 unit
Published
2026-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EHLPoint, Abrasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHLPoint, AbrasiveDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07897990399756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07897990399756078979903997567897990399756

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive disk, reusableA dental instrument consisting of a circular flat or slightly conical sheet carrying or containing 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. It is designed to be fixed at its centre to a mandrel and intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
900580358
Device count
1
DM exempt
true
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
08404535030426Brasseler USAPeter Brasseler Holdings, LLCEHL2026-09-25
08404535030433Brasseler USAPeter Brasseler Holdings, LLCEHL2026-09-25
08404535030464Brasseler USAPeter Brasseler Holdings, LLCEHL2026-09-25
08404535030488Brasseler USAPeter Brasseler Holdings, LLCEHL2026-09-25
08404535030518Brasseler USAPeter Brasseler Holdings, LLCEHL2026-09-25
08404535030549Brasseler USAPeter Brasseler Holdings, LLCEHL2026-09-25
08404535030570Brasseler USAPeter Brasseler Holdings, LLCEHL2026-09-25
08404535030600Brasseler USAPeter Brasseler Holdings, LLCEHL2026-09-25
08404535030631Brasseler USAPeter Brasseler Holdings, LLCEHL2026-09-25
08404535030662Brasseler USAPeter Brasseler Holdings, LLCEHL2026-09-25
00887919752943Brasseler USAPeter Brasseler Holdings, LLCEHL2026-07-27
04548162350558GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350565GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350572GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350589GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350596GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350602GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350619GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350626GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350633GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350640GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350657GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
04548162350664GlossMaster ZRSHOFU DENTAL CORPORATIONEHL2026-07-04
00887919711650Brasseler USAPeter Brasseler Holdings, LLCEHL2026-06-19
00887919711681Brasseler USAPeter Brasseler Holdings, LLCEHL2026-06-19
07897990301155PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990301209PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990301216PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399763PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399770PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18