FDA.reportPublic FDA data

Flex Lamineer Tips

Primary DI
07350081495336
Brand
Flex Lamineer Tips
Company
Dentatus AB
Model
LTA-F50/2
Catalog number
LTA-F50/2
Device description
2x Flex Lamineer Tips for Profin Reciprocating Contra-Angles Single Sided 50 Micron Diamond Coating
Published
2024-10-24
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
07350081495336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350081495336073500814953367350081495336

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
355803412
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350081492335SurtexRST-18RST-182025-01-30
07350081495596SurtexSST-18SST-182025-01-30
07350081495602SurtexTST-18TST-182025-01-30
07350081490515Lamineer TipsLTA-100/2LTA-100/22025-01-28
07350081490539Lamineer TipsLTA-15/2LTA-15/22025-01-28
07350081490553Lamineer TipsLTA-150/2LTA-150/22025-01-28
07350081490577Lamineer TipsLTA-30/2LTA-30/22025-01-28
07350081490591Lamineer TipsLTA-39/2LTA-39/22025-01-28
07350081490621Lamineer TipsLTA-50/2LTA-50/22025-01-28
07350081490645Lamineer TipsLTA-75/2LTA-75/22025-01-28
07350081490669Lamineer TipsLTA-C50/2LTA-C50/22025-01-28
07350081490683Lamineer TipsLTA-D100/2LTA-D100/22025-01-28
07350081490706Lamineer TipsLTA-D150/2LTA-D150/22025-01-28
07350081490720Lamineer TipsLTA-D30/2LTA-D30/22025-01-28
07350081490751Lamineer TipsLTA-D50/2LTA-D50/22025-01-28
07350081490775Lamineer TipsLTA-E50/2LTA-E50/22025-01-28
07350081490898Lamineer TipsLTA-S100/2LTA-S100/22025-01-28
07350081490911Lamineer TipsLTA-S15/2LTA-S15/22025-01-28
07350081490935Lamineer TipsLTA-S150/2LTA-S150/22025-01-28
07350081490959Lamineer TipsLTA-S30/2LTA-S30/22025-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07897990301155PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990301209PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990301216PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399756PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399763PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399770PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399787PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399794PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399800PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399817PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399824PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399831PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399848PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399855PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399862PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399886PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399893PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399909PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399916PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399923PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399930PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399947PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399954PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
08404535025101Brasseler USAPeter Brasseler Holdings, LLCEHL2026-05-11
07630049901094Diacomp flame, pu: 6 pcsDiaswiss SAEHL2023-10-02
07630049901773Diabrush cup, pu: 2 pcsDiaswiss SAEHL2023-10-02
07630049984073Diaceram 2-step cup, pu: 6 pcsDiaswiss SAEHL2023-10-02
07630049984554Diabrownies flame, pu: 6 pcsDiaswiss SAEHL2023-10-02
07630049984578Diabrownies cup, pu: 6 pcsDiaswiss SAEHL2023-10-02
07630049984592Diabrownies flame, pu: 6 pcsDiaswiss SAEHL2023-10-02