FDA.reportPublic FDA data

Profin with IPR Lamineer Tips

Primary DI
07350081496746
Brand
Profin with IPR Lamineer Tips
Company
Dentatus AB
Model
PDX-P/SK2
Catalog number
PDX-P/SK2
Device description
Profin PDX Reciprocating Contra/Angle E-Type with5x Assorted Inter-Proximal Reduction Lamineer Tips1 of each of the following:0.1mm Blade Thickness, Double Sided 15 Micron Diamond Coating0.2mm Blade Thickness, Double Sided 40 Micron Diamond Coating0.3mm Blade Thickness, Double Sided 50 Micron Diamond Coating0.4mm Blade Thickness, Double Sided 50 Micron Diamond Coating0.5mm Blade Thickness, Double 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
EGSHandpiece, Contra- And Right-Angle Attachment, Dental
EHLPoint, Abrasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1
EHLPoint, AbrasiveDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350081496746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350081496746073500814967467350081496746

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical power tool motorized handpiece/set, electricAn electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes an electric motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces and may include a rechargeable battery or a control unit; the endpieces are not included. 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
Kit
true
Lot or batch
true
Serial number
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
D77142130771Dental CityICP, INC.EGS2026-05-27
D77142131771Dental CityICP, INC.EGS2026-05-27
D77142132771Dental CityICP, INC.EGS2026-05-27
D77142133771Dental CityICP, INC.EGS2026-05-27
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
08809260470279TRAUSSaeshin Precision Co., Ltd.EGS2026-03-31
07630049901094Diacomp flame, pu: 6 pcsDiaswiss SAEHL2023-10-02